YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)

Q: What is the product code of K232230?

The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.

FDA 510(k) K232230 · Zhenjiang Assure Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK232230

Submission

Device name: YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)
Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.
Zhenjiang City, CN
Received: July 27, 2023
Decision date: October 3, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IOR – Wheelchair, Mechanical
Device class: Class I (low risk)
Regulation: 21 CFR 890.3850
Specialty: Physical Medicine

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.

Other 510(k)s with product code IOR

510(k)	Device	Applicant	Decision
K261571	Manual Wheelchair (H008, PCK7)IOR · Traditional	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	08/06/2026SE
K252370	GEN 4 JOY WheelchairIOR · Traditional	Free Wheelchair Mission	07/24/2026SE
K261076	Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional	GuangDong Yong Yi Rehabilitation Equipment…	06/22/2026SE
K261075	Manual Wheelchair (MS01);Manual Wheelchair (MA01)IOR · Traditional	GuangDong Yong Yi Rehabilitation Equipment…	06/22/2026SE
K260849	Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional	Rehasense USA, Inc.	06/11/2026SE
K260642	Manual Wheelchair (LW01108)IOR · Traditional	Anhui Longway Medical Technology Co., Ltd.	06/02/2026SE
K260295	Helio Kids; Apex PIOR · Traditional	Motion Composites	05/28/2026SE
K254141	Manual Wheelchair (DY01903(2))IOR · Traditional	Guangdong Dayang Medical Technology Co., Ltd.	05/21/2026SE
K260121	Manual Wheelchair (7101L, 7102LHD)IOR · Traditional	Foshan Nanhai Hongchen Medical Equipment Co., Ltd.	04/28/2026SE
K260319	K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional	Zhenjiang Assure Medical Equipment Co., Ltd.	03/31/2026SE

More from Zhenjiang Assure Medical Equipment Co., Ltd.

510(k)	Device	Decision
K260319	K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional	03/31/2026SE
K251159	Power wheelchairITI · Traditional	12/22/2025SE
K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS…IOR · Traditional	09/15/2023SE
K232198	Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S…IOR · Traditional	09/15/2023SE
K231320	Zhenjiang Assure Mechanical Wheelchair,model:K1IOR · Special	06/05/2023SE
K112816	Zhenjiang Asure Mechanical WheelchairIOR · Traditional	04/18/2012SE

Questions and answers

When was YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) cleared by the FDA?

YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) (K232230) received a 510(k) decision of Substantially Equivalent on October 3, 2023, 68 days after the submission was received.

What is the product code of K232230?

The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.