Product code IOR
- Device name
- Wheelchair, Mechanical
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3850
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 |
| K260319 | 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)) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026-01-12 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025-11-04 |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025-01-10 |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | 2024-10-24 |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | 2024-07-11 |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | 2024-07-05 |
| K232230 | 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... | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 |
| K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-0... | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | 2023-09-05 |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023-08-31 |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 |
| K231110 | Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2023-06-16 |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719876192295 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-09 |
| 04719876191953 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876192318 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 00840117321168 | DynaRide Pediatric Wheelchair with Footrest 12" | Dynarex Corporation | 2024-05-09 |
| 00840117321175 | DynaRide Pediatric Wheelchair with Footrest 14" | Dynarex Corporation | 2024-05-09 |
| 00840117322684 | Bariatric Reclining Wheelchair 26" with Elevating Leg Rest | Dynarex Corporation | 2024-05-08 |
| 00840117321021 | Bariatric Reclining Wheelchair 24" with Elevating Leg Rest | Dynarex Corporation | 2024-05-08 |
| 00616784024318 | DynaRide Transport Wheelchair 19", Steel | Dynarex Corporation | 2019-10-08 |
| 00616784024219 | DynaRide Transport Wheelchair 17", Steel | Dynarex Corporation | 2019-10-08 |
| 00616784024110 | DynaRide Reclining Wheelchair 22" With Detachable Desk Arm And Elevating Leg Res | Dynarex Corporation | 2019-10-08 |
| 00616784024011 | DynaRide Reclining Wheelchair 20" With Detachable Full Arm and Elevating Leg Res | Dynarex Corporation | 2019-10-08 |
| 00616784023915 | DynaRide Reclining Wheelchair 18" With Detachable Full Arm and Elevating Leg Res | Dynarex Corporation | 2019-10-08 |
| 00616784023816 | DynaRide Reclining Wheelchair 16" With Detachable Desk Arm And Elevating Leg Res | Dynarex Corporation | 2019-10-08 |
| 00616784023717 | Bariatric HD Wheelchair 30" With Elevating Leg Rest | Dynarex Corporation | 2019-10-08 |
| 00616784023618 | Bariatric HD Wheelchair 28" With Elevating Leg Rest | Dynarex Corporation | 2019-10-08 |
| 00616784022819 | DynaRide S2 Wheelchair 20" With Detachable Desk Full Arm and Foot Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022918 | DynaRide S2 Wheelchair 20" With Detachable Desk Full Arm and Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784023014 | DynaRide S3 Lite Wheelchair 18" With Elevating Leg Rest, With Detachable and Fli | Dynarex Corporation | 2019-06-24 |
| 00616784023113 | DynaRide S3 Lite Wheelchair 20" With Elevating Leg Rest, With Detachable and Fli | Dynarex Corporation | 2019-06-24 |
| 00616784023519 | Bariatric HD Wheelchair 26" With Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022710 | DynaRide S2 Wheelchair 20" With Detachable Desk Arm and Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022611 | DynaRide S2 Wheelchair 20" With Detachable Desk Arm and Foot Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022512 | DynaRide S2 Wheelchair 18" With Detachable Full Arm and Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022413 | DynaRide S2 Wheelchair 18" With Detachable Full Arm and Foot Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022314 | DynaRide S2 Wheelchair 18" With Detachable Desk Arm and Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022215 | DynaRide S2 Wheelchair 18" With Detachable Desk Arm and Foot Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022116 | DynaRide S2 Wheelchair 16" With Detachable Desk Arm and Elevating Leg Rest | Dynarex Corporation | 2019-06-24 |
| 00616784022017 | DynaRide S2 Wheelchair 16" With Detachable Desk Arm and Foot Rest | Dynarex Corporation | 2019-06-24 |
| 00616784023311 | Bariatric Wheelchair 22" With Detachable Desk Arm And Elevating Leg Rest | Dynarex Corporation | 2019-06-03 |
| 00616784023410 | Bariatric Wheelchair 24" With Detachable Desk Arm And Elevating Leg Rest | Dynarex Corporation | 2019-06-03 |