Clearance Summary
WHEELCHAIR (MANUAL, NOT ELECTRICAL) received FDA 510(k) clearance under submission number K992884, sponsored by Foshan Machinery & Equipment Import & Export Co.. 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 1999-11-02.
- Submission: K992884
- Applicant / Sponsor: Foshan Machinery & Equipment Import & Export Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1999-11-02
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.