K251083
- 510(k) number
- K251083
- Device name
- Compact II
- Applicant
- Enraf-Nonius, B.V. NL
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2025-09-12
- Date received
- 2025-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251083.pdf
Official FDA record: K251083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.