FDA warns Rapid Release Technologies that its therapeutic vibrator, which has not gone through the agency's regulatory approval process, is considered a medical device based on its intended uses. The company said it is working with FDA and consultants to comply with FDA labeling requirements.

Updated February 14, 2017

Amanda Pedersen

Therapeutic vibrators and heating pads are generally exempt from FDA's premarket approval requirements, but Rapid Release Technologies' marketing activity has landed the company in a tight spot with the U.S. regulatory agency.

According to a FDA warning letter, the company is marketing its Rapid Release Pro-2 (RRT Pro2) for uses that would make it a medical device, but the company has not applied for such an approval or for an investigational device exemption.

A spokesperson for Rapid Release told Qmed that the company is working closely with FDA, Rapid Release's own regulatory staff, and consultants to comply with all of the agency's labeling requirements. "We look forward to getting this behind us and getting back to what we do best, which is helping people have a better, fuller life." 

Generic vibrators designed to relax muscles or relieve minor aches and pains are usually allowed on the market without prior approval or clearance from FDA, and generic heating pads intended to deliver dry heat therapy for body surfaces and maintain an elevated temperature during use.

The problem with Rapid Release's device, according to FDA, is that it is being sold for the release of soft tissue, relaxation of muscle guarding (such as a protective response in muscles that results in co-contraction due to pain or fear of movement), spasms and cramps, increasing circulation, claims associated with scar tissue, mechanically affecting fascia for increasing movement, headaches, nerve or joint pain, anxiety, digestive disorders, fibromyalgia, insomnia, and hypoxia.

The agency cited 10 specific examples of marketing language on Rapid Release's websites, rapidreleasetech.com and rapidreleasecenters.com, promoting uses of the RRT Pro2 that go beyond a generic therapeutic vibrator or heating pad.

"Our office requests that Rapid Release Technologies immediately cease activities that result in the misbranding or adulteration of the RRT Pro2, such as commercial distribution of the device for the uses discussed," the warning letter states.

FDA directed the company to information on the agency's website regarding what it needs to submit in order to get approval or clearance to legally market the device. Failure to correct the violations addressed in the warning letter could result in further regulatory action, including seizure, injunction, and civil money penalties, the agency noted.

The warning letter was issued Jan. 17, and as recently as Feb. 10 the company was actively promoting an ongoing February giveaway of a Rapid Release Pro-2 device, for which it has already received more than 50 entries.

Stanley Stanbridge, a practicing chiropractor, invented the device and serves as the company's president. According to the company, Stanbridge was an early adopter whose research involving high-speed vibrations, their affect on scar tissue, and the combined effects of arc motion with the shearing force of planar waves led to the formation of Rapid Release Technologies. The company said the technology is used by physical therapists, chiropractors, sports trainers, and the health and medical community in general.

"We all have a choice to do what we do, however I feel like from the very first astonishing successes I had with my patients in February 2010, when I made the first Rapid Release device, I haven't a choice in the matter," Stanbridge said on the company's website. "I have to do this with you and anybody else who can invest in our vision."

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image courtesy of Pixabay]