Reprieve by RegenesisTM— 510(k) K223620
Substantially EquivalentRegenesis Biomedical, Inc.
FDA 510(k) clearance K223620 for Reprieve by RegenesisTM, Substantially Equivalent on 2023-05-24. Applicant: Regenesis Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Regenesis Biomedical, Inc.
- Product code
- Code IMJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5290
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code IMJ
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