Clearance Summary
CoolTone received FDA 510(k) clearance under submission number K251378, sponsored by Zimmer Medizinsysteme GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-07-14.
- Submission: K251378
- Applicant / Sponsor: Zimmer Medizinsysteme GmbH
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2025-07-14
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.