ViVY— 510(k) K250376
Substantially EquivalentViatherm Therapeutics, LLC
FDA 510(k) clearance K250376 for ViVY, Substantially Equivalent on 2025-11-05. Applicant: Viatherm Therapeutics, LLC. Device class: 2.
Clearance details
- Applicant
- Viatherm Therapeutics, LLC
- 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
- Pittsburgh, PA, US
Recent devices under product code IMJ
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