Clearance Summary
MP3HD BIG BOY, POWER WHEELCHAIR received FDA 510(k) clearance under submission number K010380, sponsored by Merits Health Products., Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2001-05-09.
- Submission: K010380
- Applicant / Sponsor: Merits Health Products., Inc.
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2001-05-09
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.