Clearance Summary
BUDDY WHEELCHAIR received FDA 510(k) clearance under submission number K960402, sponsored by Metro-Care. 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 1996-02-16.
- Submission: K960402
- Applicant / Sponsor: Metro-Care
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1996-02-16
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.