Flexx-HD

Primary DI

04719873857104

Basic UDI-DI Code

471987385KM-8000GM

Reference

110404000086

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Karma Medical Products Co., Ltd

Flexx HD (KM-8022 HD / KM-8522 HD) Product Description: The Flexx HD is a heavy-duty, highly adjustable wheelchair designed for users requiring a more robust support system. Available in both fixed backrest (KM-8022 HD) and foldable backrest (KM-8522 HD) versions, this self-propelled or attendant-propelled wheelchair is constructed with a durable aluminum alloy frame. It features ergonomic handrims, 24" solid rear wheels, 7" front casters, and flip-back armrests. Key adjustment components are color-coded for intuitive operation, and all contact points avoid direct metal exposure in use. Intended Usage: The Flexx HD is intended for a single user weighing up to 170 kg, making it suitable for heavier individuals needing enhanced stability. It is designed for indoor use and limited outdoor mobility, and offers flexible configuration for different clinical needs, including those of amputees or users with altered center of gravity. It may be used either independently by the user or pushed by an attendant.

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

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