Background
On 7 April 2025, the Advertising Codes were updated to reflect the revocation and restatement of the Consumer Protection from Unfair Trading Regulations 2008 (CPRs – the legislation from which the majority of the CAP and BCAP rules on misleading advertising derived) by the Unfair Commercial Practices provisions in the Digital Markets, Competition and Consumers Act 2024 (DMCCA). On that date, the wording of a number of the rules in the Advertising Codes was changed to reflect relevant changes introduced by the DMCCA on 6 April 2025.
Given that the complaint that formed the subject of this Ruling was received before 7 April 2025, the ASA considered the ad and complaint under the wording of the rules that existed prior to 7 April 2025, and the Ruling (and references to rules within it) should therefore be read in line with this wording, available here – CAP Code and BCAP Code.
Summary of Council decision:
Three issues were investigated, one of which was Not upheld, and two of which were Upheld.
Ad description
A TV ad for Actegy’s Revitive device, seen in October 2023, began with two older women sitting at a table outside. One of the women winced and rubbed her calves. The second woman asked, “Your legs aching again?”. She replied, “I’m not sure I can face the walk back” and then spotted Sir Ian Botham walking his dogs and said, “What’s Botham’s secret?”. The women speculated as to whether it was “daily massage” or a “cocktail of pills”. The second woman concluded, “I hear he uses Revitive”.
The ad cut to Sir Ian sitting at a desk with his feet on the Revitive device. In voice-over he said, “Revitive Circulation Booster: get your leg muscles pumping to relieve leg aches and pains, and reduce swelling. And it’s drug-free”. A close-up of his legs featured graphics of waves pulsing up from the Revitive device, causing his calf muscles to contract. Large on-screen text stated, “Revitive – Relieves leg aches & pains – Reduce swelling”. Small on-screen text stated, “following 8 weeks use”. The next scene showed both the women and Sir Ian walking outside, in different clothing to that shown in the initial scenes.
Small on-screen text shown at the start of the ad stated, “Always read the instructions. Consult doctor if symptoms persist […] Unsuitable for certain conditions, see revitive.com”. A final shot featured the large on-screen text “REVITIVE Best Kept Secret for Aching Legs”.
Issue
The complainant challenged whether the claims:
- “Revitive Circulation Booster gets your leg muscles pumping to relieve leg aches and pains”;
- “Revitive Circulation Booster gets your leg muscles pumping to […] reduce swelling”; and
- the implied claim that use of Revitive could improve walking distance and duration;
were misleading and could be substantiated.
Response
Actegy Ltd said that the Revitive family of devices were registered as Class IIa medical devices under the UK Medical Devices Regulations 2002 (UK MDR). They provided certification to that effect. They confirmed the device featured in the ad was the Revitive Medic (model number 5573AQ).
They highlighted that the people featured in the ad looked to be of retirement age, which was reflective of Actegy’s key target group and the main users of the Revitive device.
1. Actegy explained that the Revitive Medic delivered electrical energy to the nerves of the feet and lower legs via footpads. That electrical stimulation to the nerves caused the muscles in the lower legs to contract. The device was set at an intensity level between 1 and 99 by the user. The instructions for the device directed users to set the intensity high enough to achieve a strong but comfortable muscle contraction, which was usually achieved at an intensity level over 40. The reference in the ad that the device “gets your leg muscles pumping” indicated that this was needed in order to achieve the claimed effects.
The claim “Revitive Circulation Booster gets your leg muscles pumping to relieve leg aches and pains” was approved by Clearcast’s consultant, who had reviewed a statistical report of a study conducted between July 2019 and October 2022. They provided a copy of that statistical report. A paper detailing the study had been submitted to a journal in April 2023, but publication had been delayed until August 2024 as the journal had not been able to find experts to complete the peer review process. They provided a copy of the submitted manuscript and the final published paper during the ASA’s investigation.
The study was a participant-blinded, parallel-group, randomised and placebo-controlled interventional trial carried out over an eight-week period, with a follow-up at 12 weeks. Two groups received different treatment programs using a Revitive Medic device (‘Program 1’ and ‘Program 2’) and a third group received a sham treatment.
Actegy said treatment Programs 1 and 2 demonstrated a significant reduction in leg pain compared to the sham device. Significantly more participants in the treatment groups achieved a minimal clinically important difference in pain reduction score (i.e. a 2-point reduction in pain on a 10-point scale) compared to the sham groups. They said both Programs also demonstrated a significant reduction in leg aches compared to the sham device. They confirmed that Program 1 was the same as the “Medic” preset program setting on the advertised device. However, Program 2 was not available on the advertised device.
2. Actegy said that an ASA Ruling published in 2014 had found that evidence showed “that when used for 10 to 20 minutes the device offered temporary relief from swelling and its associated discomfort and poorer circulation in healthy people”. That assessment was based on two study reports from 2011. They said the device on which the studies were carried out was functionally equivalent to the 2023 Revitive Medic; all Revitive Circulation Booster devices were designed to be clinically, technically and biologically equivalent. That equivalence was confirmed in May 2024 by an independent third party which reviewed Actegy’s documentation relating to their compliance with EU medical device guidelines. Differences between the devices had been analysed and not deemed relevant for device safety and clinical performance.
They acknowledged that ASA Rulings published in 2018 and 2021 had found there was not adequate evidence that their devices could help to reduce swelling in individuals with chronic venous disease. However, the claim in the ad under investigation related to the reduction of swelling in healthy individuals, as did the evidence assessed in the 2014 Ruling; that evidence was therefore relevant to the claim now under investigation.
Actegy said that information gathered in a customer survey, and from data gathered by the Revitive Medic Coach app, consistently reported high user satisfaction in those affected by swelling. They provided an internal report dated November 2024, but said its details were confidential because they were preparing it for publication. Based on that data, they would amend the ad to clarify that individual results may vary in terms of swelling reduction.
If the ASA did not consider that data to be adequate to support the claims, they said they would be willing to add further text on-screen to clarify that the reduced swelling effect of the device occurred only during device use, to reflect the findings of the ASA’s 2014 Ruling.
3. Actegy said the ad was constructed to avoid any implication that the character was physically unable to walk due to her symptoms. The ad was light-hearted in tone and was intended to communicate that the device could result in enhanced enjoyment during daily activities, such as walking. The presence of the women in the park made it evident that walking remained a regular and manageable activity for them. They were not shown in a way that would suggest their mobility was compromised; for example, they were not shown struggling to walk or stopping due to discomfort.
The wording of the query about whether the woman’s legs were “aching” again was chosen deliberately, because aches would be understood as a benign, transient symptom, especially among older individuals. Because the woman was smiling and laughing slightly when she said “I’m not sure I can face the walk back” it would not be taken literally; she was clearly happy and relaxed. She did not say she was unable to walk back, just that she did not wish to do so because of her aching legs. That was a common scenario for older people who remained active and mobile. The viewer was invited to identify with the emotional response of low energy or tiredness, not a loss of function. Actegy therefore did not consider that the ad could reasonably be interpreted as implying that use of the Revitive device could result in an improvement in walking distance or duration without experiencing the symptoms referenced in the ad.
They said there was nothing in the ad that expressly made any claim in relation to duration or distance of walking, and no efficacy claims were made during the walking sequence at the end. They considered it did not depict Sir Ian or the two women as walking fast or energetically; they were shown enjoying a relaxed, gentle walk, at a normal pace, and no increase in their pace was observed. The walking pace was actually moderated at Sir Ian’s request, and the women adjusted accordingly. There was nothing to indicate the distance or duration of that walk.
The sequence was included to provide context for the story in the ad and to underscore the importance of overall physical activity, including walking, as an integral part of a healthy lifestyle, particularly in older people. They provided a range of documents from organisations such as the UK’s Department of Health and Social Care and the World Health Organisation relating to that. They said global regulators increasingly expected manufacturers to show that medical devices supported, rather than replaced, an active lifestyle. The walking scene and café setting reflected not just activity, but sociability, routine and wellbeing. Additionally, they understood their customers were seeking symptom relief that enabled them to continue their routines with greater enjoyment and less discomfort, rather than athletic improvement.
Therefore, while the Revitive devices alleviated symptoms independently of exercise, Actegy considered it important to encourage an active lifestyle for a range of reasons, including because they did not want to portray their devices as the sole answer to leg symptoms. They therefore emphasised in their ads activities such as walking. Removing those cues would risk undermining important behavioural messages that encouraged physical activity and social engagement, particularly in older audiences.
Notwithstanding that, they added that the study referenced at Point 1 substantiated that use of the device led to the enhanced enjoyment of daily activities such as walking. The primary outcome measure for the study was a commonly used occupational performance measure (the COPM-P) designed to measure self-perception of physical functioning performance. A secondary outcome measure, the COPM-S, related to participants’ satisfaction with the results of the intervention they received. Participants were asked to identify, at baseline, activities where they experienced issues. Actegy highlighted that across all three groups, 85 participants identified walking and 61 identified stair climbing. They said participants reported clinically meaningful improvements in both performance and satisfaction when comparing results from Program 1 and the sham device.
1., 2., & 3. Clearcast believed the supporting data provided by Actegy, along with advice from Clearcast’s consultant, was commensurate with the claims.
Assessment
1. Not upheld
The ad included the claim “Revitive Circulation Booster gets your leg muscles pumping to relieve leg aches and pains”. Taken together with the small on-screen text which stated, “following 8 weeks use”, the ASA considered viewers would understand that regular use of the device over eight weeks would reduce the frequency and intensity of leg aches and pains in otherwise generally healthy older people.
Under the CAP Code, medical claims could be made for devices bearing UK Conformity Assessed (UKCA) marking, provided they complied with other requirements of the Codes, including those relating to substantiation. We understood that the Revitive Medic was UKCA marked and classified as a Class IIa medical device. However, this in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims.
We took expert advice on the evidence. Study participants rated their leg pain at baseline and weeks eight and 12, on an 11-point numerical scale. Participants were considered to have responded to device use if they showed a 30% reduction in pain score. The percentage of ‘responders’ in each group was 36% of the sham device group and 68% of the Program 1 treatment group. That amounted to a significant difference between the groups. The expert agreed with the report’s conclusion that the use of the Revitive Medic device twice per day for eight weeks increased the likelihood of a clinically significant reduction in leg pain.
The study also scored various symptoms, including “feeling of aching in the legs”. Participants rated symptoms on a 10-point scale for each of seven days of weeks zero, eight and 12. The Program 1 treatment group recorded a significant reduction in aching compared to the sham group. The expert said it was not clear whether this was a clinically significant improvement for individuals, but that it could be stated that the use of the Revitive Medic for eight weeks led to a reduction in the feeling of aching in the legs for that treatment group.
The study’s primary outcome measure related to a commonly used occupational performance measure (the COPM-P) designed to measure self-perception of physical functioning performance. Participants were considered to be responders if they demonstrated a two-point improvement in their score. The study recorded 61% of responders in the Program 1 treatment group and 20.5% in the sham group. The expert said it could be stated with reasonable confidence that use of the Revitive Medic device twice per day for eight weeks increased the likelihood of a clinically significant improvement in performance of physical function. They added that the highly significant COPM-P result increased the confidence in the results of the secondary outcome measures such as pain and aching.
The expert noted the published study did not differ in any significant way from the statistical report, and that it was a well-designed and well-executed study. They concluded it had a few, relatively minor methodological weaknesses, but provided a moderate quality of evidence to support claims that the device could relieve leg aches and pains in otherwise generally healthy older people.
The ASA considered that the study would ideally have been peer-reviewed and published before Actegy began to make advertising claims based on its findings. However, we noted that the 2022 statistical report they had provided to Clearcast during the clearance process did not differ significantly from the manuscript submitted for publication in April 2023 or the article finally published in August 2024. We noted the claims relating to leg aches and pains were therefore based on evidence collated and analysed prior to the ad being broadcast.
While there were methodological weaknesses in the study, we understood it was of moderate quality and that its findings supported claims that the Revitive Medic device could help to reduce leg aches and pains in older, generally healthy people when used twice daily for eight weeks. As referenced above, we considered viewers would understand the ad to mean that regular use of the device over eight weeks would reduce the frequency and intensity of leg aches and pains in otherwise generally healthy older people. We concluded that the evidence provided was adequate to substantiate those claims.
On that point, we investigated the ad under BCAP Code rules 3.1 (Misleading advertising), 3.9 (Substantiation) and 11.2 and 11.4 (Medicines, medical devices, treatments and health), but did not find it in breach.
2. Upheld
The ASA considered viewers would understand the claim “Revitive Circulation Booster gets your leg muscles pumping to […] reduce swelling”, appearing in conjunction with the scene of Sir Ian using the device, and the small on-screen text “following 8 weeks use”, to mean that regular use of the Revitive Medic device over eight weeks would reduce the amount of swelling in the legs of otherwise generally healthy older people. We therefore expected to see evidence to support that claim.
Actegy had referred to an ASA Ruling in 2014 which found that a qualified claim to help swelling could be made in relation to the device being sold at that time – the “Circulation Booster”. The ASA had sought expert advice in relation to a range of evidence in that investigation. One study conducted in 2011 looked at 16 healthy volunteers who had blood pooling and swelling induced by sitting still for 40 minutes (stasis). The subjects were then stimulated using the device at 50% of their pain threshold for 10 minutes and they reported a significant reduction in the swelling in the leg and foot. Another study conducted in 2011 on 13 healthy volunteers, who had the same stasis but had stimulation for 20 minutes, reported a significant reduction in swelling. The expert considered the studies showed a reduction in swelling immediately after use of the device for 10 to 20 minutes. The ASA’s 2014 Ruling concluded that when used for 10 to 20 minutes the device offered temporary relief from swelling and its associated discomfort in healthy people.
We understood the “Circulation Booster” device was functionally equivalent to the 2023 Revitive Medic, and we therefore considered the results from the two 2011 studies could be extrapolated to the Revitive Medic. We also reviewed the more recent evidence provided. The study conducted from 2019 to 2022 did not assess reduction of swelling as an outcome measure and therefore was not relevant to advertising claims in that regard.
We did not assess in detail the November 2024 report which collated data from customer surveys and the Revitive Medic Coach app, because it post-dated Clearcast’s approval of the ad for broadcast. We also considered that such data was not sufficiently robust to support advertising claims, because it related only to self-reported outcomes by device users in unmonitored settings. There was no non-intervention/sham group with which to compare the data. Furthermore, because the baseline and outcome measurements were self-reported by people who had purchased the device, those outcomes were subject to selection bias and the placebo effect.
We considered that the 2011 studies substantiated the use of a qualified claim that the Revitive Medic could provide a temporary (i.e. during use) reduction in swelling when used for 10 to 20 minutes – in healthy people. However, the claim in the ad did not make clear that the reduction in swelling was temporary and based on use of the device for 10 to 20 minutes. We therefore concluded the ad’s claim “Revitive Circulation Booster gets your leg muscles pumping to […] reduce swelling” was not adequately substantiated and was misleading.
On that point, the ad breached BCAP Code rules 3.1 (Misleading advertising), 3.9 (Substantiation), 11.2 and 11.4 (Medicines, medical devices, treatments and health).
3. Upheld
We considered the ad presented a scenario which suggested that an older woman who had previously suffered from leg aches which impacted her ability to walk was able to walk comfortably after using the device, and that Sir Ian had a similar experience. This was emphasised by the different scenarios presented at the beginning and end of the ad: the two women were only shown sitting down at the start of the ad, with one in pain; they were only seen walking, comfortably and with energy, at the end. We considered the overall presentation of the ad implied that, for generally healthy older people who had experienced aches and pains when walking, using the Revitive Medic device could improve the distance and duration they would be able to walk without experiencing aches and pains.
One of the studies assessed in our 2021 Ruling used the primary outcome measure of walking distance to assess the device’s efficacy. That study found no statistical difference between a control group who followed a structured exercise programme and a treatment group who followed the same exercise programme and used the device.
Actegy had referred to the study conducted from 2019 to 2022. They highlighted the results of the COPM-P (noted above at Point 1) and COPM-S outcome measures. With regard to COPM-S, the study recorded that 73.2% of participants in the Program 1 treatment group were responders regarding their satisfaction with their physical function, compared to 18.2% in the sham group. However, those results did not specifically relate to the activity of walking. Instead, the results were aggregated from all activities identified by participants, which also included stair climbing, sleeping, sitting, standing and ‘general daily activities’. The study did not include an analysis of the results specifically relating to participants who had identified walking as an activity of issue. We understood that was because there were not sufficient numbers of those participants in each of the intervention groups for the results to be statistically significant. The study therefore did not adequately address the device’s efficacy in relation to improving walking distance or duration.
We concluded that we had not seen evidence to substantiate the implied claim in the ad that use of the Revitive Medic device could improve the distance and duration that generally healthy older people could walk without experiencing aches and pains. That implied claim was therefore misleading.On that point, the ad breached BCAP Code rules 3.1 (Misleading advertising), 3.9 (Substantiation), 11.2 and 11.4 (Medicines, medical devices, treatments and health).
Action
The ad must not appear again in its current form. We told Actegy Ltd not to make advertising claims that the Revitive Medic device, or other NMES (neuromuscular electrical stimulation) devices they sold, could reduce swelling unless it was qualified to make clear that this was in relation to healthy people, and was a temporary result of using the device for 10 to 20 minutes. We also told them to ensure their ads did not make stated or implied claims that the Revitive Medic device, or other NMES devices they sold, could improve walking distance and duration for people who experienced aches and pains from walking, unless they held adequate evidence which was relevant to the group to whom the ad was targeted.
