Clearance Summary
W2 WRIST CPM UNIT received FDA 510(k) clearance under submission number K950682, sponsored by Toronto Medical 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 1995-09-13.
- Submission: K950682
- Applicant / Sponsor: Toronto Medical Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1995-09-13
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.