# K123076: Profthand Mechanical Wheelchair

- Pathway: 510(k) (Abbreviated)
- Applicant: Harmony Hill International
- Decided: Aug 9, 2013 after 312 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922535 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083231: Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT, Panthera Production AB (2009) Summary page 2.

## Indications for use
Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.

Source page: https://510kreport.com/device/K123076
Methodology: https://510kreport.com/methodology