Clearance Summary
MODEL 1100 COLD THERAPY DEVICE received FDA 510(k) clearance under submission number K970533, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1997-04-15.
- Submission: K970533
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5720
- Decision date: 1997-04-15
Classification & Regulation
This clearance is catalogued under FDA product code ILO and 21 CFR 890.5720, within the Physical Medicine review panel as a Class II device.