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

Flexx S

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

Basic Information

Primary DI
04719873857128
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 S Series (KM-8022S / KM-8522S) Product Description: The Flexx S Series is a configurable, lightweight wheelchair that is part of the broader Flexx lineup. It includes standard upholstery, flip-back armrests for easier transfers, and pull-to-lock brakes for added safety. The KM-8022S features a fixed backrest, while the KM-8522S includes a foldable backrest to enhance storage and transport convenience. Built with a durable aluminum alloy frame and designed for user comfort and safety, the Flexx S Series has been crash tested and meets ISO 7176-19 standards, making it suitable for use as a seat in adapted vehicles. The design includes ergonomic handrims, solid 24" rear wheels, and 7" front casters. Intended Usage: The Flexx S Series is intended for a single user up to 130 kg and is designed for both self-propelled and attendant-assisted use. It is suitable for indoor and limited outdoor environments, and, importantly, it is certified for use as a seat in specially adapted vehicles, providing secure transportation for wheelchair users. Its adjustable features and safety compliance make it a reliable option for daily mobility and travel.

CND Nomenclature Codes

Code Description
Y122106 REAR SELF-PROPELLED WHEELCHAIRS
Y122103 PUSH WHEELCHAIRS

Related Devices

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).

View all