What is FDA product code IOR?

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

Physical Medicine › ProstheticWheelchair, Mechanical

WC Advantage 36+

Name: WC Advantage 36+
Brand: WC Advantage 36+

Catalogue number WCADV36+, listed by Sizewise Rentals, L.L.C., under Wheelchair, Mechanical. 46 manufacturers in China are registered for this product code.

Registry build 21.09.26

46manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (4). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IOR
Manufacturer	City	Province	Registered as	Device types
Kunshan Hi-Fortune Health Products Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	32
Merits Healthcare Industries. (Suzhou) Co., Ltd.	Jiangsu	Jiangsu	Contract manufacturer	31
Trolli King (Holding) Ltd.	Shenzhen	Guangdong	Contract manufacturer	23
Jiangsu Assure Medical Equipment Co., Ltd.	Zhenjiang	Jiangsu	Contract manufacturer	18
Foshan Shunkangda Medical Tech Co., Ltd.	Foshan	Guangdong	Contract manufacturer	16
Raise Medical Industries, Inc.	Foshan	Guangdong	Contract manufacturer	16
Jiaxing Xinyi Medical Instrument Co., Ltd.	Jiashan	Zhejiang	Contract manufacturer	12
Zhenjiang Kawaza Medical Products Co., Ltd.	Zhenjiang	Jiangsu	Contract manufacturer	10
Jiangsu Pinkang Medical Technology Co Ltd	Danyang	Jiangsu	Contract manufacturer	8
Fujian Pacific Medical Manufacturing Co., Ltd.	Yunxiao County	Fujian	Contract manufacturer	6
Xiamen Taft Medical Co., Ltd.	Xiamen	Fujian	Contract manufacturer	6
Imami Toys Hebei Co., Ltd.	Handan	Hebei	Contract manufacturer	2

Showing 12 of 46. All 46 manufacturers in China registered for Wheelchair, Mechanical

Record

Regulatory record for WC Advantage 36+
Listed by	Sizewise Rentals, L.L.C.
FDA product code	IOR
Device type	Wheelchair, Mechanical
Device class	Class 1
Regulation	21 CFR 890.3850
510(k)	K961514
Record published	2019-01-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for WC Advantage 36+
Catalogue number	Size	Status
WCADV36+		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Drivemedical	Drive DeVilbiss Healthcare	329
Drive	Drive DeVilbiss Healthcare	303
Gendron	GF Health Products, Inc	158
Everest & Jennings	GF Health Products, Inc	106
Probasics	Drive DeVilbiss Healthcare	75
Evermed	Xiamen Taft Medical Co., Ltd.	48
Convaid	Convaid Products LLC	46
Karman Healthcare	Karman Healthcare Inc.	41
Medline	Medline Industries, Inc.	40
Cardinal Health	Cardinal Health 200, LLC	38
Dalton Manual Wheelchair	Dalton Technology, Inc.	37
Merits	Merits Health Products, Inc.	35

Showing 12 of 226. All products under Wheelchair, Mechanical

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.