K253408
- 510(k) number
- K253408
- Device name
- CoolTone
- Applicant
- Zimmer Medizinsysteme GmbH DE
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2026-01-16
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253408.pdf
Official FDA record: K253408
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.