Clearance Summary
WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER received FDA 510(k) clearance under submission number K950701, sponsored by Wahl Clipper Corp.. 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 1995-03-24.
- Submission: K950701
- Applicant / Sponsor: Wahl Clipper Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5730
- Decision date: 1995-03-24
Classification & Regulation
This clearance is catalogued under FDA product code IMA and 21 CFR 890.5730, within the Physical Medicine review panel as a Class I device.