K251905
- 510(k) number
- K251905
- Device name
- Normatec Elite Hip
- Applicant
- NormaTec Industries, LP MA · US
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-09-18
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K251905.pdf
Official FDA record: K251905
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.