# K111045: Centro Family of Manual Wheelchairs

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare LP
- Decided: Jul 15, 2011 after 91 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: 1 generation back to K052681 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052681: Start Family of Manual Wheelchairs (Basic, Plus, Multi and Hemi), Otto Bock Healthcare LP (2005) Summary page 1.

## Indications for use
The Centro wheelchairs are designed solely for individual use by persons who are unable to walk or who have a walking impediment, and can be operated either by the patient or by another person. Centro wheelchairs are suitable for patients with walking impediments/inability due to, but not limited to: * Palsies/Paralyses * Defective and/or deformed limbs * Loss of limb (leg amputation) * Joint contractures/defects * Diseases such as cardiac or circulatory insufficiency, balance disorders or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

Source page: https://510kreport.com/device/K111045
Methodology: https://510kreport.com/methodology