Clearance Summary
P & F POWER WHEELCHAIR, MODEL HC-500SB received FDA 510(k) clearance under submission number K082722, 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 2008-10-28.
- Submission: K082722
- 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: 2008-10-28
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.