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Klaxon

FDA UDI

Class II (US FDA UDI)

by Ki Mobility, Llc

Identity

Trade Name
Klaxon FDA UDI
Generic Name
Wheelchair electric-motor-driven propulsion system FDA UDI
Device Name
Battery powered power add-on designed to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. FDA UDI
Model / Reference
Twist FDA UDI
Description
Battery powered power add-on designed to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. FDA UDI

Identifiers

Catalog Number
123882 FDA UDI
Primary DI / UDI-DI
00840363369082 FDA UDI
FDA Product Code
ITI FDA UDI
GMDN Term
Wheelchair electric-motor-driven propulsion system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wheelchair electric-motor-driven propulsion system

Klaxon by Ki Mobility, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair electric-motor-driven propulsion system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ki Mobility, Llc

Sources (1)

  • FDA UDI c1a4ec79-2c33-4c22-a9f8-612ed6f18521 36 fields · synced May 30, 2026