# K111278: Z10 Wheelchair Push and Brake Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare LP
- Decided: Sep 16, 2011 after 134 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K900565 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073701: Dane Technologies Wheelchair Mover, Model WM 2000, Dane Technologies (2008) Summary page 1.

## Indications for use
Provide mobility to persons physically challenged and limited to sitting positions due to: * Paisies/Paralyses * Loss of limbs * Defective and/or deformed limbs * Joint contractures * Joint defects * Other diseases

Source page: https://510kreport.com/device/K111278
Methodology: https://510kreport.com/methodology