Clearance Summary
P&F POWER WHEELCHAIR, HC-510 received FDA 510(k) clearance under submission number K070350, sponsored by P & F Brother Ind., Corp.. 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 2007-03-14.
- Submission: K070350
- Applicant / Sponsor: P & F Brother Ind., Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2007-03-14
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.