# K123769: ZX-I Power Add on

- Pathway: 510(k) (Traditional)
- Applicant: Spinergy, Inc.
- Decided: May 10, 2013 after 154 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: 1 generation back to K943789 (1994). 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)
- K943789: Power Wheelchair Conversion Kit, Alber Technologies, Inc. (1994) Summary page 1.

## Indications for use
The ZX- I is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.

Source page: https://510kreport.com/device/K123769
Methodology: https://510kreport.com/methodology