WARNING LETTER
Rapid Release Technologies MARCS-CMS 507144 —
- Delivery Method:
- United Parcel Service
- Recipient:
-
Recipient NameDr. Stanley R. Stanbridge
- Rapid Release Technologies
3621W. MacArthur Blvd. Ste. 111
Santa Ana, CA 92704
United States
- Issuing Office:
- Los Angeles District Office
United States
| |
Los Angeles District 19701 Fairchild Road Los Angeles, CA 92612 |
WARNING LETTER
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
January 17, 2017
WL #12-17
Dr. Stanley R. Stanbridge
Vice President of R&D
Rapid Release Technologies
3621W. MacArthur Blvd, Ste. 111
Santa Ana, California 92704-6843
Re: RRT PRO2
Refer to CMS 507144
Dear Dr. Stanbridge:
During an inspection of your firm located in Santa Ana, California, on May 17, 2016 through May 25, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the RRT PRO2.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
The FDA has reviewed the RRT PRO2 user’s manual, and your firm’s websites, rapidreleasetech.com and www.rapidreleasecenters.com, and determined that the RRT PRO2 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.
The RRT PRO2 is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5975 (therapeutic vibrator – product code IRO),and at 21 CFR 890.5740 (powered heating pad – product code IRT) without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
A review of Rapid Release Technologies’ FDA registration and listing had revealed that the RRT PRO2 is listed under 21 CFR 890.5975 (therapeutic vibrator). Devices classified under 21 CFR 890.5975 (therapeutic vibrator) are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). We also note that the RRT PRO2 contains a heating element. Devices classified under 21 CFR 890.5740 (powered heating pad) are also exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a).
There is evidence that the RRT PRO2 is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5975 (therapeutic vibrator), and 21 CFR 890.5740 (powered heating pad). Generic therapeutic vibrator devices are intended for uses such as relaxing muscles and relieving minor aches and pains and generic powered heating pads are intended for medical purposes that provide dry heat therapy for body surfaces and are capable of maintaining an elevated temperature during use. However, your firm is marketing the RRT PRO2 for different intended uses, namely for the release of soft tissue, relaxation of muscle guarding (e.g., 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. Examples include:
• “…releases tension in soft tissue related conditions affecting muscles, nerves, tendons, ligaments and fascia.”
• “It produces high frequency compression waves at a frequency that resonates with scar tissue adhesions while also triggering the Tonic Vibration Reflex to relax muscle guarding, spasms and cramps.”
• “The RRT is intended for increasing circulation, relief of muscle cramps and spasms…”
• “..effect on scar tissue adhesions…” and “…breaks down adhesions…”
• “…increase the Hyaluronic acid pressure in the Fascia, easing movement…”
• “…helpful for: Anxiety, Digestive disorders, Fibromyalgia, Headaches, Insomnia related to stress, Myofascial pain syndrome, Paresthesias and nerve pain, Soft tissue strains or injuries, Sports injuries, and Temporomandibular joint pain.”
• “Releases even the most Chronic Pain”
• “Ankle injuries can include Sprains, Strains, and Fractures. Ankle pain and injuries shouldn't be the end of your career or active life. Rapid Release Technology was created with this type of injury in mind…”
• Achilles injuries shouldn't be the end of your career or active life. Rapid Release Technology was created with this type of injury in mind, and it has taken the medical world by storm.
• “The Rapid Release Pro2 quickly and easily melts the scar tissue and removes adhesions in the carpal tunnel, hand, wrist and forearm.”
Because there is evidence that the RRT PRO2 is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5975 (therapeutic vibrator) and 21CFR 890.5740 (powered heating pad), it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency; 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Rapid Release Technologies immediately cease activities that result in the misbranding or adulteration of the RRT PRO2, such as the commercial distribution of the device for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Kelly D. Sheppard
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the identification number CMS 507144 when replying. We remind you that only written communication is considered as official. If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov or Rochelle Rolnik, Acting Compliance Officer, at 949-608-4496 or rochelle.rolnik@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Sincerely
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
Cc:
David M. Mazzera, Ph.D., Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence