K241685
- 510(k) number
- K241685
- Device name
- SofWave System
- Applicant
- Sofwave Medical, Ltd. IL
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2024-08-07
- Date received
- 2024-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241685.pdf
Official FDA record: K241685
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.