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

KM-8000

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

Basic Information

Primary DI
04719873857050
Basic UDI-DI Code
471987385KM-8000GM
Reference
110404000004
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

Product Description: The KM-8000 Series is a high-performance, self-propelled wheelchair equipped with 24-inch rear wheels, allowing it to be operated independently by the user or pushed by an attendant. The series includes multiple models: KM-8020/KM-8520, suitable for users up to 130 kg. KM-8020X/KM-8520X, reinforced models suitable for users up to 160 kg. Each model features hand brakes on both rear wheels, pneumatic rear tires for improved traction and comfort, and PU casters for added durability (with pneumatic caster options available upon request). The frame is made of extremely durable aluminum alloy, ensuring structural integrity and reliability under various temperature conditions. Optional solid PU rear tires are also available. Additionally, the KM-8000 system offers enhanced pressure relief, body stabilization, and reduction of user sliding, improving comfort and safety during extended use. Intended Use: The KM-8000 Series is intended to provide mobility support for individuals with limited walking ability or physical disabilities, offering both user-driven and attendant-assisted operation. Designed for indoor and outdoor use, the wheelchair is suitable for a single user up to the specified weight limit per model, helping users maintain independence and mobility in a variety of environments.

CND Nomenclature Codes

Code Description
Y122103 PUSH WHEELCHAIRS
Y122106 REAR SELF-PROPELLED WHEELCHAIRS

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