# K240267: Klaxon (Twist); Klaxon (Twist R)

- Pathway: 510(k) (Traditional)
- Applicant: Klaxon Mobility GmbH
- Decided: Jan 10, 2025 after 345 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: 2 generations back to K151199 (2015). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192016: Smoov O10, Alber GmbH (2020) Summary page 5.

## Most influential descendants
- K250748: Klaxon (Twist); Klaxon (Twist R) (2025), 0 descendants of its own

## 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/K240267
Methodology: https://510kreport.com/methodology