Clearance Summary
BIOTECH POWERED WHEELCHAIR, C650PW received FDA 510(k) clearance under submission number K011846, sponsored by Roc Chinese-European Industrial Research Society. 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 2002-01-18.
- Submission: K011846
- Applicant / Sponsor: Roc Chinese-European Industrial Research Society
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2002-01-18
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.