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Provant Infinity
Regenesis Biomedical, Inc. · Model 4210 · UDI-DI 00868924000021
ILX
Prescription
1
510(k) clearances
9
Adverse events
1
Recalls
7
Facilities
Description
The device includes a Control Unit and Treatment Applicator. The Control Unit is enclosed in a UL-compliant injection-molded case made of medical grade polycarbonate. The device also includes a Treatment Applicator and an external power supply that are attached to the Control Unit. When not in use, the device is stored inside the carrying case. The device may be removed from the carrying case prior to administration of therapy. Provant Infinity 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.