K250817
- 510(k) number
- K250817
- Device name
- Coretech Compression System (Coretech RHB3003)
- Applicant
- Vive Health, LLC FL · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2025-08-08
- Date received
- 2025-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250817.pdf
Official FDA record: K250817
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.