Navigo

The JWX-1 Plus, marketed as Navigo 16 or Navigo 24, is an add-on drive that converts a manually propelled wheelchair into a powered wheelchair. The filing says the drive units replace the…

Registry build 21.09.26

The JWX-1 Plus, marketed as Navigo 16 or Navigo 24, is an add-on drive that converts a manually propelled wheelchair into a powered wheelchair. The filing says the drive units replace the wheelchair’s original wheels.

The system can use Yamaha nickel-metal-hydride or lithium-ion batteries. The filing describes recharging with the ESC3 charger and notes that the lithium-ion battery may also be charged while mounted on the wheelchair.

Drive and Battery

The source identifies the wheelchair conversion role and the drive-unit configuration. It names compatible batteries and the charger used to recharge them.

62manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code

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 Navigo
Listed by Yamaha Motor Co Ltd, Japan
FDA product code ITI
Device type Wheelchair, Powered
Device class Class 2
Regulation 21 CFR 890.3860
Establishment Manufacturer
510(k) K203806
Record published 2021-12-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Navigo
Catalogue number Size Status
X0FC In distribution
X0FD In distribution
X0FD In distribution
X0FC 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
K252101 2026-03-19
K203806 2021-05-21
K140204 2014-08-28

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