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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rapid Recovery Health Services Inc. 07-Mar-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Devices and Radiological Health
9200 Corporate Blvd
Rockville, MD 20850




MAR 7 2005

WARNING LETTER

FEDERAL EXPRESS

Mr. Scott Warantz
Rapid Recovery Health Services Inc.
30 Hopper Street
Westbury, New York 11590

Dear Mr. Warantz:

The Food and Drug Administration (FDA) has reviewed information from you website,www.rapidrecoveryinc.com, relating to extracorporeal shockwave therapy (ESWT) devices. The website promotes the Sonocur® and the Epos Ultra for the relief of pain in the elbow, hand/wrist, shoulder, and knee/heel, as well as for other tendon-associated pains. The website indicates that your company will provide the Sonocur or the Epos Ultra to a practitioner's office, along with a technician trained to use the device . The technician will then administer the device on patient(s) under the practitioner's supervision.

Under the Federal Food, Drug, and Cosmetic Act (the Act), the Sonocur and the Epos Ultra 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 to affect the structure or a function of the body (section 201(h) of the Act, 21 U.S.C.321(h)). The law requires that certain devices be approved or cleared by FDA before they may be marketed or offered for sale . This helps to ensure that these devices are either safe and effective or substantially equivalent to other devices already legally marketed in this country.

In a letter dated November 26, 2003, we advised you that the Sonocur was approved only for the treatment of chronic lateral epicondylitis in patients with symptoms for at least six months and a history of unsuccessful conservative treatments . We also advised you that the approved indications for use did not include treatment of pain the hand/wrist, shoulder, or knee/heel (plantar fasciitis), or other tendon-related problems, like those described on your website. The Epos Ultra has been approved only for the treatment of chronic plantar fasciitis in patients with symptoms for at least six months and a history of unsuccessful conservative treatments . It has not been approved for treatment of pain in the hand/wrist, shoulder, or elbow, or for other tendon-related pain. PMA approval for the treatment of pain in the aforementioned areas is required before the devices may be marketed or offered for sale for those uses.

Your promotion and introduction into interstate commerce of the Sonocur and Epos Ultra devices for these unapproved indications renders them adulterated under section 501(f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).

There are many FDA requirements pertaining to the manufacture, distribution, and marketing of devices. This letter does not address all of the obligations you have under the law. You may obtain general information about FDA's requirements applicable to devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at (800) 638-2041 or through the Internet at http://www.fda.gov.

You should know that these serious violations of the law may result in the FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. FDA may assess civil money penalties against you as an individual, and against Rapid Recovery Inc., for violations of Section 301(a) of the Act, i.e., the introduction or delivery for introduction into interstate commerce of any . . .device. . .that is adulterated or misbranded. Under Section 303(f)(1)(A) of the Act, FDA may impose civil money penalties of up to $15,000 on you as an individual for each violation of a requirement of the Act, up to a total of $1,000,000 per respondent for all violations.

Federal agencies are advised of all warning letters about devices so that they may take this information into account when considering the award of contracts. Also, no requests for Certificates for Export will be approved until the violations related to the subject device have been corrected.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Sonocur and Epos Ultra comply with each applicable requirement of the Act and FDA regulations.

You should take prompt action to correct these violations. 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 or civil penalties.

Please provide this office in writing within fifteen (15) working days of receipt of this letter a report of the specific steps you have taken, or will take to comply with this request. We request that you notify this office in writing of the steps you are taking to correct the noted violations. We also ask that you explain how you plan to prevent this from happening again. Please address your response to:

William MacFarland, Chief
Orthopedic, Physical Medicine & Anesthesiology Devices Branch HFZ-343
Division of Enforcement B, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850

If you have any questions, please contact Mr. Willam MacFarland at (240) 276-0120.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health