K251378
- 510(k) number
- K251378
- Device name
- CoolTone
- Applicant
- Zimmer Medizinsysteme GmbH DE
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2025-07-14
- Date received
- 2025-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251378.pdf
Official FDA record: K251378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.