IOR · Wheelchair, Mechanical · Chrysalis Intelligence

Device class

Class I

Regulation 890.3850

Total clearances

2020-04-01 → 2026-08-06

Last 12 months

Unique sponsors

Definition

What is Wheelchair, Mechanical

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.

Classification details

Medical specialty

Physical Medicine

Review panel

Regulation number

890.3850

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Zhenjiang Assure Medical Equipment Co., Ltd.	5	1	2026-03-31
Ningbo Shenyu Medical Equipment Co.,Ltd	3	1	2025-10-03
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.	3	3	2026-01-29
Sichuan Ast Medical Equipment Co., Ltd.	2	0	2024-11-22
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.	2	2	2026-06-22
Ki Mobility, LLC	2	0	2023-09-05
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	1	1	2026-08-06
Karma Mobility Co, Ltd.	1	1	2025-11-04
Anhui Longway Medical Technology Co., Ltd.	1	1	2026-06-02
Suzhou Master Machinery Manufacturing Co.,Ltd	1	1	2025-11-21
Turbo Wheelchair Co., Inc.	1	0	2024-07-05
Rehasense USA, Inc.	1	1	2026-06-11
Guangdong Dayang Medical Technology Co., Ltd.	1	1	2026-05-21
Panthera AB	1	0	2023-02-16
Free Wheelchair Mission	1	1	2026-07-24
Motion Composites	1	1	2026-05-28
Anhui Jbh Medical Apparatus Co., Ltd.	1	0	2025-02-28
Rgk Wheelchairs, Ltd.	1	0	2020-09-10
Bowhead Design Corp.	1	0	2025-01-10
Jerry Medical Instrument (Shanghai) Co., Ltd.	1	0	2020-04-01
Foshan Nanhai Hongchen Medical Equipment Co., Ltd.	1	1	2026-04-28
Power Plus Mobility	1	0	2022-10-28
Mobility Source Medical Technology Co., Ltd.	1	0	2022-03-14
Roughrider America, LLC	1	0	2022-06-24
Empower Ride, LLC	1	1	2026-01-12

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
E1130	HCPCS	Standard wheelchair, fixed full length arms, fixed or swing away detachable footrests ✓ CMS-verified description	High	HCPCS code for standard manual wheelchair

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-06	K261571	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	Manual Wheelchair (H008, PCK7)
2026-07-24	K252370	Free Wheelchair Mission	GEN 4 JOY Wheelchair
2026-06-22	K261076	GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.	Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)
2026-06-22	K261075	GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.	Manual Wheelchair (MS01);Manual Wheelchair (MA01)
2026-06-11	K260849	Rehasense USA, Inc.	ICON 35; ICON 45; ICON 60; ICON 30FAF
2026-06-02	K260642	Anhui Longway Medical Technology Co., Ltd.	Manual Wheelchair (LW01108)
2026-05-28	K260295	Motion Composites	Helio Kids; Apex P
2026-05-21	K254141	Guangdong Dayang Medical Technology Co., Ltd.	Manual Wheelchair (DY01903(2))
2026-04-28	K260121	Foshan Nanhai Hongchen Medical Equipment Co., Ltd.	Manual Wheelchair (7101L, 7102LHD)
2026-03-31	K260319	Zhenjiang Assure Medical Equipment Co., Ltd.	K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
2026-01-29	K253632	Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.	Manual Wheelchair (W50)
2026-01-12	K251886	Empower Ride, LLC	EmpowerRide NAVIGATOR
2025-12-05	K252828	Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.	Manual Wheelchair (W47)
2025-12-05	K252825	Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.	Manual Wheelchair (W45)
2025-11-21	K252687	Suzhou Master Machinery Manufacturing Co.,Ltd	Manual Wheelchair (HM305-Air1, HM305-Air2)
2025-11-04	K250576	Karma Mobility Co, Ltd.	Flexx Junior (FLX-J00, FLX-J50)
2025-10-03	K252517	Ningbo Shenyu Medical Equipment Co.,Ltd	Manual Wheelchair (SYIV100A008)
2025-02-28	K241374	Anhui Jbh Medical Apparatus Co., Ltd.	Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
2025-01-10	K243111	Bowhead Design Corp.	Bowhead ERA Wheelchairs
2024-11-22	K242722	Sichuan Ast Medical Equipment Co., Ltd.	Manual Wheelchair (MASY23)
2024-10-24	K242560	Foshan Shunkangda Medical Tech Co., Ltd.	Manual Wheelchair (SYIV100-CA9221)
2024-07-11	K241460	Lichtmega Technology Co., Ltd.	Manual Wheelchair
2024-07-05	K240120	Turbo Wheelchair Co., Inc.	Merlexi Craft Bariatric series of manual wheelchairs
2023-10-03	K232230	Zhenjiang Assure Medical Equipment Co., Ltd.	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)
2023-09-15	K232199	Zhenjiang Assure Medical Equipment Co., Ltd.	Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)