Source: https://www.casewatch.net/fdawarning/prod/2008/rebuilder.shtml
Timestamp: 2019-04-25 05:46:04+00:00

Document:
FDA Warning Letter to ReBuilder Medical Technologies, Inc.
The Food and Drug Administration (FDA) has reviewed your website at http://www.ReBuildermedical.com for the ReBuilder® and ReBuilder® EMS devices and learned that your firm is marketing the ReBuilder® and ReBuilder® EMS devices in the United States (U.S.) for new intended uses without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products are devices within the meaning of section 201(h) of the Act 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 because they are intended to affect the structure or any function of the body, 21 U.S.C. § 321 (h).
The devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that a notice or other information respecting the devices for the new uses listed below was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii). Your promotion of the ReBuilder® and ReBuilder® EMS devices for intended uses that are not consistent with those cleared in your 510(k) Premarket Notifications represents a change in the intended therapeutic effect or a major change or modification in the intended use that requires the submission of a PMA or a 510(k), respectively. For a device requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending before the agency, 21 C.F.R. § 807.81(b).
The ReBuilder® was cleared under K874085 as a prescription device intended for the symptomatic relief of chronic intractable pain. The ReBuilder® EMS/TENS was cleared under K882980 as a prescription device for the following uses: relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle reeducation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, maintaining or increasing range of motion, symptomatic relief of chronic intractable pain, and post-traumatic and post-surgical pain relief.
These intended uses are significant modifications to the cleared intended use of your devices and require submission of a new premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81 (a)(3)(ii).
Your devices are also misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for the devices fails to bear adequate directions for use for the purposes for which they are intended and the devices are not exempt from the requirements of this section under 21 C.F.R. § 801.109(a)(2).
Your establishment registration for the above devices is not current for 2008, and there is no device listing for your devices. Consequently, your devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C § 360; were not included in a list as required by 21 U.S.C. § 360(j); and a notice or other information respecting the devices was not provided to the FDA as required by 21 U.S.C. § 360(k).
You should take prompt action to correct these deviations. Specifically, FDA requests that you cease dissemination of promotional materials for the ReBuilderTM and ReBuilderTM EMS devices that contain new intended uses, as described above. Further information regarding the requirements for 510(k)s may be found at the FDA website at: http://www.fda.gov/cdrh/devadvice/314.html1.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your labeling and promotional materials for the ReBuilder® and ReBuilder® EMS devices comply with each applicable requirement of the Act and FDA implementing regulations. Failure to promptly correct the violations discussed may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please let this office know in writing what steps you have taken to correct these problems within fifteen (15) working days from the date you receive this letter. Please include a list of all labeling and promotional materials for your devices, the same as or similar to those described above, and explain your plan for discontinuing use of such materials. We also ask that you explain how you plan to prevent this from happening again. Please direct your response to William C. MacFarland, Acting Chief, Cardiovascular & Neurological Devices Branch, HFZ-341, Office of Compliance, at the Food and Drug Administration, 2098 Gaither Road, Rockville, Maryland 20850, facsimile at 240-276-0325.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter only pertains to the issues of premarket review for your devices and select labeling issues and does not necessarily address other obligations you have under the law.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 360
 § 807
 § 360
 § 352
 § 801
 § 352
 § 360
 § 360
 § 360