Is this your brand? Sign in to claim ownership.
Sign in to claim this brandREGENESIS BIOMEDICAL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5301 N Pima Rd Ste 150, SCOTTSDALE, AZ, 85250
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003070149
- DUNS Number
- —
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Provant Infinity | 4210 | FDA UDI | Class II | Unknown |
| Reprieve by Regenesis | A | FDA UDI | Class II | Active |
| Disposable Applicator Cover | PVTC30 | FDA UDI | Class II | Unknown |
| Provant Therapy System | 4201 | FDA UDI | Class II | Unknown |
| Regenesis Model 42 | K972093 | FDA 510(k) | Class II | Active |
| Provant System, Model 4201 | K091791 | FDA 510(k) | Class II | Active |
| Provant Therapy System | K131979 | FDA 510(k) | Class II | Active |
| Reprieve by RegenesisTM | K223620 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 29, 2008 | Z-0887-2009 | — | terminated | 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. |