Coretech Compression System (Coretech RHB3003)
510(k) K250817
Coretech Compression System (Coretech RHB3003) is a medical device (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Vive Health LLC, cleared under FDA 510(k) K250817 on 8 Aug 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250817 | Date8 Aug 2025 | StatusActive |
Official records
- FDA 510(k) database K250817
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOW
- FDA applicant
- Vive Health, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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