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

SM-100.3

Karma Medical Products Co., Ltd · 🇹🇼 Taiwan
Devices (same UDI-DI)
4
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04719873857418
Basic UDI-DI Code
471987385SM-100HE
Reference
104-40109
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

Product Description: The SM-100.3 is a versatile wheelchair designed for both self-propelled and attendant-propelled use. When equipped with 14” rear wheels, it functions solely as a transit wheelchair. It features pneumatic tires for improved traction and ride comfort, hand brakes on both rear wheels for control, and a highly durable aluminum alloy frame. The frame is built to withstand extreme temperature conditions and is designed so that users and attendants do not come into direct contact with metal surfaces during normal use. The wheelchair is suitable for users weighing up to 100 kg. Intended Usage: The SM-100.3 wheelchair is intended for indoor and outdoor mobility support for individuals with limited or impaired walking ability. It can be propelled by the user or an attendant, depending on the wheel configuration. For users with altered center of gravity—such as amputees or individuals with certain disabilities—professional guidance from a therapist or dealer is recommended, and the use of anti-tippers is advised for safety.

CND Nomenclature Codes

Code Description
Y122103 PUSH WHEELCHAIRS
Y122106 REAR SELF-PROPELLED WHEELCHAIRS

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The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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