Clearance Summary
PROFTHAND MECHANICAL WHEELCHAIR received FDA 510(k) clearance under submission number K123076, sponsored by Harmony Hill International. 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 2013-08-09.
- Submission: K123076
- Applicant / Sponsor: Harmony Hill International
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2013-08-09
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.