What is FDA product code ITI?

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

JWX-2 · Wheelchair, Powered → Physical Medicine

Name: JWX-2
Brand: JWX-2

62manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

6recalls on this 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 JWX-2
Listed by	Sunrise Medical (US) LLC, United States
FDA product code	ITI
Device type	Wheelchair, Powered
Device class	Class 2
Regulation	21 CFR 890.3860
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K140204
Record published	2016-08-23
Record revised	2025-05-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Latex	Labelled latex-free
Label carries	serial number
Distribution end date	2021-05-03

Catalogue Numbers

Catalogue numbers for JWX-2
Catalogue number	Size	Status
XT		Withdrawn

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
K220213	2022-03-30
K160031	2016-07-14
K142457	2014-12-18

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-02-13	Class II	Software Design Change	Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.	1	2021-04-28
2008-01-11	Not classified	Software design	Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.	141 units total	2009-11-16
2008-01-11	Not classified	Software design	Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.	141 units total	2009-11-16
2007-04-23	Not classified	Component design/selection	The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.	229 Enhanced Display units (affecting 220 wheelchairs)	2008-03-25
2006-11-13	Not classified	Device Design	Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.	36 units	2009-12-22
2005-11-15	Not classified	Other	While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.	5 units	2006-12-28

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.

JWX-2