# K250748: Klaxon (Twist); Klaxon (Twist R)

- Pathway: 510(k) (Special)
- Applicant: Klaxon-Mobility GmbH
- Decided: Apr 11, 2025 after 30 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: 3 generations back to K151199 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240267: Klaxon (Twist); Klaxon (Twist R), Klaxon Mobility GmbH (2025) Summary page 5.

## Indications for use
The TWIST and TWIST R are add-on drive accessories for wheelchairs. The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.

Source page: https://510kreport.com/device/K250748
Methodology: https://510kreport.com/methodology