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510(k) Data Aggregation
K Number
K250748Device Name
KLAXON (TWIST); KLAXON (TWIST R)
Manufacturer
KLAXON-MOBILITY GmbH
Date Cleared
2025-04-11
(30 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
KLAXON-MOBILITY GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The device is an add on accessory for manual wheelchairs.
### 1. TWIST
TWIST device is meant to be added to the wheelchair in 5 different combinations of position and control:
1. Front mounted without handlebar, driven by the wheelchair occupant
2. Front mounted without handlebar, driven by the attendant
3. Front mounted position with handlebar, driven by the wheelchair occupant
4. Rear mounted without handlebar, driven by the wheelchair occupant
5. Rear mounted without handlebar, driven by the attendant
Coupling the TWIST device in front position to the wheelchair raises the front castors off the ground. The single wheel of the "traction unit" is then used for steering.
### 2. VARIATION TWIST R
VARIATION TWIST R device is meant to be added to the wheelchair in 1 only position (rear) and 2 ways of control
1. Rear mounted without handlebar, driven by the wheelchair occupant
2. Rear mounted without handlebar, driven by the attendant
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