K241601
- 510(k) number
- K241601
- Device name
- EMS (FlexPulse, MagnaCore, Magnetika)
- Applicant
- Cpmt Laser (Canadian Pioneer Medical Technology Corporation) CA
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2025-02-25
- Date received
- 2024-06-04
- 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: K241601.pdf
Official FDA record: K241601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.