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Provant Therapy System
Regenesis Biomedical, Inc. · Model 4201 · UDI-DI 00868924000007
ILX
Prescription
10
510(k) clearances
8
Adverse events
1
Recalls
7
Facilities
Description
The device includes a Control Unit and Treatment Applicator. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy. The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-29 | Regenesis Biomedical Inc | In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio f |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.