K251594
- 510(k) number
- K251594
- Device name
- truFlex
- Applicant
- Syrma Johari Medtech Limited IN
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2025-08-28
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251594.pdf
Official FDA record: K251594
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.