Concourse Assistivetechnology PTY Ltd

The M90 is a medical device that allows a user to add a powered option to a manual wheelchair. The design intent is to be as non-intrusive and easy to integrate with a manual wheelchair as…

Registry build 21.09.26

The M90 is a medical device that allows a user to add a powered option to a manual wheelchair. The design intent is to be as non-intrusive and easy to integrate with a manual wheelchair as possible. This has myriad benifits to the end user, such as a sleek and subtle design with wireless operation, expedient configuration by the dealer/ocupational therapist, and ability to add a powered option to a wheelchair that the user is familiar with. The M90 is intended to be used to provide power assistance to manual wheelchair users who are limited in their field of activities because of their physical conditions. It is designed to augment or replace the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. The M90 will be used by: • Wheelchair Occupant • Carer • Therapist • Technician and Installer • Sales Personnel

62manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITI
Manufacturer City Province Registered as Device types
Merits Healthcare Industries. (Suzhou) Co., Ltd. Jiangsu Jiangsu Contract manufacturer 31
Chiaphua Components (Jiangxi) Limited Yichun Jiangxi Contract manufacturer 23
Feishen Group Co., Ltd. Yongkang Zhejiang Contract manufacturer 22
Guangdong Marshell Electric Vehicle Co., Ltd. Zhaoqing Guangdong Contract manufacturer 22
Viscount HI-Tech (Huizhou) Co., Ltd. Huizhou Guangdong Contract manufacturer 17
Zhejiang Linix Motor Co., Ltd. Dongyang Zhejiang Contract manufacturer 4
Jiangsu Bangbang Intelligent Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 2
Jinhua Ruidi Vehicle Industry Co Ltd Zhejiang Zhejiang Contract manufacturer 2
Suzhou Green Pine Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 2
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Kunshan Hi-Fortune Health Products Co., Ltd. Kunshan Jiangsu Contract manufacturer 32
Zhenjiang Assure Medical Equipment Co Ltd Zhenjiang Jiangsu Contract manufacturer 18

Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered

Record

Regulatory record for Concourse Assistivetechnology PTY Ltd
Listed by Concourse Assistive Technology PTY Ltd, Australia
FDA product code ITI
Device type Wheelchair, Powered
Device class Class 2
Regulation 21 CFR 890.3860
Establishment Manufacturer
510(k) K242327
Record published 2025-03-11

Specifications

Specifications
MRI safety MR Unsafe
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Concourse Assistivetechnology PTY Ltd
Catalogue number Size Status
M90 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Merits Merits Health Products, Inc. 186
e-motion® Alber Gmbh 129
Modular Power Positioning System Motion Concepts 112
e-fix® Alber Gmbh 56
TRZ-CG Power Positioning System Motion Concepts 54
Batec Batec Mobility SL. 48
Drive Drive DeVilbiss Healthcare 47
Invacare® TDX® Power Wheelchair Invacare GmbH 43
Drivemedical Drive DeVilbiss Healthcare 34
Heartway Medical Products Co., Ltd. Heartway Medical Products Co., Ltd. 20
Scout Burke, Inc. 20
Power Wheelchair Zhejiang Innuovo Rehabilitation Devices Co., Ltd. 18

Showing 12 of 277. All products under Wheelchair, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K242327 2024-12-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer