Clearance Summary
STANNAH POWER CHAIR, MODEL 201 received FDA 510(k) clearance under submission number K994083, sponsored by Stannah Power Chairs , Ltd.. 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 2001-04-04.
- Submission: K994083
- Applicant / Sponsor: Stannah Power Chairs , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 2001-04-04
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.