Data / Medical devices / United States / Regenesis Biomedical, Inc.
Regenesis Biomedical, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 2 510(k) clearances
Regenesis Biomedical, Inc. is registered with the FDA (registration 2032108) in Scottsdale, AZ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 24, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2032108
- FEI number
- 3003070149
- Address
- 5301 N Pima Rd Ste 150, Scottsdale, AZ, United States, 85250
- Owner or operator
- REGENESIS BIOMEDICAL, INC. (9030652)
- Roles
- Specification developer
- First device listed
- December 14, 2017
- Registered through
- 2026
- Brand names listed
- Provant Therapy System, Reprieve by Regenesis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | 2 | Specification developer | accessdata.fda.gov |
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2023 | K223620 | Reprieve by RegenesisTM | IMJ | Substantially Equivalent | Regenesis Biomedical, Inc. | accessdata.fda.gov |
| December 13, 2013 | K131979 | PROVANT THERAPY SYSTEM | ILX | Substantially Equivalent | Regenesis Biomedical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 29, 2008 | 50230 | Not yet classified | Terminated | Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized me | 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 frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired. | accessdata.fda.gov |
Compare with other makers
- All makers of Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- All makers of Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Updated May 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.