James G. Cole
- SonicLife.com, LLC
1027 Industrial Loop, Suite B
Hood River, OR 97031
- Issuing Office:
- Seattle District Office
December 22, 2015
In reply refer to Warning Letter SEA 16-06
James G. Cole, Owner
1027 Industrial Loop, Suite B
Hood River, Oregon 97031
Dear Mr. Cole:
During an inspection of your firm located in Hood River, Oregon, on June 1, 2015, through July 2, 2015, investigators from the United States Food and Drug Administration (FDA) determined that your firm is the initial importer and distributor of whole body vibration devices that include Professional VC-12, Pulsation VM-10, and Personal VH-11. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. As explained below, these devices are being marketed without required clearance or approval in violation of the Act.
Under Title 21 Code of Federal Regulations (CFR) Part 890.5380, although powered exercise equipment intended for medical purposes are Class I devices exempt from the premarket notification procedures under Subpart E of 21 CFR part 807, they are subject to the limitations in 21 CFR 890.9. These limitations provide, in relevant part, that “manufacturers . . . must still submit a premarket notification to FDA . . . when . . . [t]he device is intended for a use different from the intended use of a legally marketed device in that generic type of device . . . .” 21 CFR 890.9.
Generic devices of this type (e.g., a powered treadmill, a powered bicycle, and powered parallel bars) are intended for limited medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Our inspection revealed, however, that your firm markets the Professional VC-12, Pulsation VM-10 and Personal VH-11 whole body vibration devices with therapeutic and/or structure/function claims that exceedthe limitations of the intended uses for powered exercise equipment. These promotional claims include, but are not limited to, the following:
- “…improve muscular endurance by stimulating HGH, human growth hormone, improve performance of slow twitch muscle fibers…”
- “Sonic Life Exercise Offers Improvements of: …Drainage and Clearing of Lymphatic Fluids…Rehabilitation of Injuries…Collagen Production…Secretion of Hormones such as HGH-Human Growth Hormone, IGF-1 & Testosterone…Creation of…Hormone Serotonin & Norepinephrine…Bone Density…”
- “…improves blood, oxygen and lymph circulation, which can also contribute to the prevention of metabolic, musculoskeletal [sic], and degenerative disorders…”
- “…rehabilitation of women with Knee osteoarthritis…”
- “…help to lower Cortisol, a stress hormone…resulting in a natural, drug-free pain management exercise system without side effects…”
- “Sonic Whole Body Vibration plus Oxygen…Anerobic [sic] pathogens, parasites or a disease-condition cannot survive a highly oxygenated environment, including the blood stream of the Human body…”
Because your firm’s whole body vibration devices are distributed with intended uses that are different from the intended use of a legally marketed device under 21 CFR 890.5380, the devices exceed the limitations described in 21 CFR 890.9 and are not exempt from premarket notification.
Therefore, the Professional VC-12, Pulsation VM-10, and Personal VH-11 whole body vibration devices are 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the FDA of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
For a device requiring premarket approval, the notification required by section 510(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.
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 (15) 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 recurring. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that 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 (15) 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: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. Refer to the identification number WL SEA 16-06 when replying. If you have any questions about the content of this letter, please contact: Compliance Officer Jessica L. Kocian at 425-302-0444.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your marketing of these devices and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Miriam R. Burbach