I may need to start a new series
First some history. I have a gym membership, and I spend some time on the treadmill. The treadmills come equipped with cable TV, and you can punch in the channel you want. I was strolling and scanning CNN when they went to a commercial break. The first thing that caught my attention was this.
Some call me skeptical, and some call me cynical, but I’m cool with that. No surprise ,the first thing that popped into my mind was the F-word. No, it’s not the word you’re thinking of, but it’s a word you do not use when describing somebody’s business if you don’t want to get sued.
So I watched the ad, and I figured it would show up on YouTube back home, and here it is. Follow the link to watch.
Listening, I caught the correct pronunciation, and it’s re-VI-tive. You purchase one of these things—easy payment terms are offered—and you crank it up and put your feet on it—don’t know if you’re supposed to stand on it—and it sends electrical impulses into your legs, causing your muscles to contract and not, and the result is supposed to be less pain. Assuming you had pain to begin with.
Here’s a guy using it sitting down. The claim is you only need one session a day.
See the image at the top. This is “clinically proven.” Do we know what that means? They don’t elaborate. They do mention—see image number 2 above—the device is “FDA Cleared.” I wondered about that. They have an ad site on the Web, and there is additional language:
FDA Cleared: Giving you peace of mind
OK, not much. Another site was more informative:
What Does “FDA Cleared” Mean?
According to the organization, FDA cleared means that a device has been submitted to the FDA along with a 510(k) premarket notification, showing that it is “substantially equivalent to a device that is already legally marketed for the same use.”
In other words, “FDA cleared” does not mean that the FDA has approved the device, that they’ve confirmed it works as advertised, or that they’ve even tried it in the first place.
The Food and Drug Administration explains more on their site: From there I snooped further and pulled up this document. I have a copy in case this link ever goes stale, and the critical wording is this:
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002 John J. Smith, MD, JD
Regulatory Counsel
Hogan Lovells US LLP
Columbia Square 555 13th Street, NW
Washington, DC 20004
Re: K143207
Trade/Device Name: Revitive IX (OTC)
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: NGX, NUH
Dated: November 7, 2014
Received: November 7, 2014Dear Dr. Smith,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go tohttp://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S for
Carlos L. Peña, PhD, MS
Director
Division of Neurological
and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
I have omitted some uninteresting stuff to leave room for the uninteresting stuff I did not omit. I am sure you are as impressed at the thoroughness of our government agencies as I was upon going through this very professionally-prepared document.
Final analysis: the FDA has not tested this device, and it goes without saying they are not vouching for its effectiveness. Buy it if you wish. Use it if you wish. Complain or don’t complain. Some have (excerpts):
15 Consumer Reviews for Revitive (2.7 on a scale of 1 to 5)
Got scammed by these guys
I tried to place an order yesterday, May 16th, at 3:49 AM and their associate said my order did not go through. I told her to hold while I call Discover and she agreed. I get through to Discover and they said she put two charges on my card for $394. She did not hold one minute to hear this. I called back several times to speak to supervisors and other associates on phone, and now they give me the run around that they do not see my name in their system nor phone number. Two charges pending on my credit card are sure showing up for $394. I have contacted to inform them of their scamming associates. Never will I attempt to do business with this company!
Bottom Line: No, I would not recommend this to a friend
Swollen leg and ankle.
Swollen right leg and ankle for nearly three years and getting worse. Arthritic right foot too. Leg scan last week showed no clots. Compression socks helped a but slow progress. After only three days of Revitive use while watching the 6 o’clock news, leg calf and ankle is back to normal size, foot is much better too, and pain is gone. Believe it!
Bottom Line: Yes, I would recommend this to a friend [gave it 5 stars]
Disappointment
I don’t know if you can say it’s a fake or scam, but it’s not any good if you have much pain. It may help tired feet and legs, but it’s worthless when it comes to diabetic pain. I think it’s way overpriced, and I’d never buy one thinking it was going to help, believe me, I have one built in. I know they will never print this because they know it’s the truth, I’ve been typing this just for fun I guess, but I tried. Good luck, I hope it helps you more than it did me.
Bottom Line: No, I would not recommend this to a friend [gave it 1 star]
It may not be the snake oil of legend, but it could pass for the son of snake oil.
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