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

KM-5000

Karma Medical Products Co., Ltd · 🇹🇼 Taiwan
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04719873857029
Basic UDI-DI Code
471987385KM-5000FY
Reference
110400001422
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The Ergo Recline series is a lightweight, foldable wheelchair available in two configurations: A self-propelled version with 20″ rear wheels, allowing independent operation by the user or assisted pushing by an attendant. A transit version with 14″ rear wheels, designed for attendant-assisted mobility only. Both models are constructed with a durable aluminum alloy frame, equipped with robust accessories and PU rear tires for enhanced durability. The design ensures safe and comfortable use across varying temperature conditions, with no exposed metal parts requiring direct contact during normal operation. Intended Use: The Ergo Recline wheelchair is intended to provide mobility assistance for individuals with limited or impaired walking ability. It is suitable for users weighing up to 115 kg, and is designed for both indoor and outdoor environments. The self-propelled model supports user independence, while the transit model is tailored for full-time caregiver or attendant support.

CND Nomenclature Codes

Code Description
Y122103 PUSH WHEELCHAIRS
Y122106 REAR SELF-PROPELLED WHEELCHAIRS

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