Eu Mdr Eu Md Class 1 On The Market 🇹🇼 Taiwan

Flexx

Karma Medical Products Co., Ltd · 🇹🇼 Taiwan
Devices (same UDI-DI)
6
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04719873857098
Basic UDI-DI Code
471987385KM-8000GM
Reference
110404000082
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

Flexx Series (KM-8022 / KM-8522) Product Description: The Flexx Series is a versatile, lightweight wheelchair available in both self-propelled and transit configurations. It features a strong yet lightweight aluminum alloy frame with durable accessories and excellent temperature resistance. The KM-8022 model has a fixed backrest, while the KM-8522 comes with a foldable backrest for enhanced portability. Standard features include 24" solid rear wheels with ergonomic handrims, 7" solid front casters, hand brakes on both rear wheels, and color-highlighted key lock components for intuitive operation of flip-back armrests and swing-away footrests. Designed with adjustability in mind, many components are detachable and easy to modify for individual needs. Intended Usage: The Flexx Series is intended for a single user weighing up to 130 kg. It is suitable for both indoor and limited outdoor use and can be used either independently by the user (self-propelled) or with the help of an attendant (transit model). Due to its high level of adjustability, it is also appropriate for users with complex needs, including amputees or individuals with shifting center-of-gravity issues—though clinical consultation is advised in such cases.

CND Nomenclature Codes

Code Description
Y122103 PUSH WHEELCHAIRS
Y122106 REAR SELF-PROPELLED WHEELCHAIRS

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