ITI
585 FDA 510(k) clearances · Product code
86 daysmedian time to decision
255 days90th percentile
585clearances measured
FDA profile
- Official device name
- Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- FDA definition
- 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).
- Adverse events (MAUDE)
- 2021: 166 · 2022: 135 · 2023: 223 · 2024: 146 · 2025: 651 · 2026: 455
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Electric Wheelchair (DY611A-2, DY612A-1) (K261149) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 |
| Electric Wheelchair (K261396) | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 |
| Electric wheelchair (XW-LY007 ) (K261164) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (K260937) | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 |
| Power Wheelchair (W5915B, W5915C, W5915D) (K253812) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 |
| Electric Wheelchair (S500-6) (K260335) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| WHILL (WHILL Model C2) (K261175) | Whill, Inc. | 2026-06-12 |
| Power Wheelchair (N5515A, N5516, N5517A, N5519) (K260056) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 |
| Electric Wheelchair (DF506) (K260373) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 |
| Electric Wheelchair (Y207BL) (K253241) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 |
| Power Wheelchair (N5919 series) (K253806) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 |
| Power Wheelchair (OS-R-M01S) (K253952) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 |
| Electric Wheelchair (AL-208S-063) (K253340) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 |
| Electric wheelchair (K253307) | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 |
| Power wheelchair (ZS-EW8026) (K254206) | Ningbo Zhishan Medical Technology Co., Ltd. | 2026-03-27 |
| Electrically Powered Wheelchair (Model YC-01) (K253980) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 |
| Electric Wheelchair (E201) (K254012) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | 2026-03-24 |
| Electric wheelchair (JJW-7002, JJW-7003) (K253849) | ZheJiang J&J Mobility Co., Ltd. | 2026-03-20 |
| JWG-1 (K252101) | Yamaha Motor Co., Ltd. | 2026-03-19 |
| Electric Wheelchair (MP148) (K253870) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2026-03-04 |
| Electric wheelchair (K253789) | Zhejiang Yikang Medical Technology Co., Ltd. | 2026-02-25 |
| Electric wheelchair (W1,W3) (K253707) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-24 |
| Electric Wheelchair (W-A807, W-A807L) (K253599) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2026-02-17 |
| Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) (K253276) | Shanghai Bangbang Robotics Co., Ltd. | 2026-01-15 |
| Electric Wheelchair (DH01168) (K251458) | Foshan Dahao Medical Technology Co., Ltd. | 2026-01-15 |
| Power wheelchair (K251159) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2025-12-22 |
| Electric Wheelchair (DH01126) (K252862) | Foshan Dahao Medical Technology Co., Ltd. | 2025-12-08 |
| Electrically powered wheelchair (KZ301B) (K252494) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-12-05 |
| Powered Wheelchair (PL001-9001) (K252829) | Suzhou KD Intelligent Device Co., Ltd. | 2025-11-12 |
| Electric Wheelchair (Rollz Motion Electric 2M) (K250819) | Rollz International BV | 2025-11-07 |
| Electric wheelchair (NSDS-01) (K252671) | Hebei Dansong Medical Technology Co., Ltd. | 2025-11-03 |
| Wheelchair (N817) (K251565) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | 2025-10-06 |
| Electric Wheelchair (Model P2) (K252428) | Superpi Robot Co., Ltd. | 2025-09-18 |
| Electric Wheelchair (GY-E001) (K251891) | Shandong Guyue Healthcare Appliance Co., Ltd. | 2025-09-09 |
| Power Wheelchair (MOB1107) (K250729) | Vive Health, LLC | 2025-07-02 |
| Electric Wheelchair (HG-630) (K251285) | Zhejiang Automwheel Tech Co., Ltd. | 2025-07-02 |
| Power Wheelchair (D26) (K251606) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-06-25 |
| ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) (K251248) | Jinhua Qidian Vehicle Co., Ltd. | 2025-06-20 |
| Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (K250475) | Ningbo Baichen Medical Devices Co., Ltd. | 2025-05-27 |
| Electric Wheelchair (F309) (K250758) | Changshu Pingfang Wheelchair Co., Ltd. | 2025-05-09 |
| eFOLDi Navigator Powerchair (STPC-A) (K243110) | Suntech UK , Ltd. | 2025-05-08 |
| Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) (K250158) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | 2025-04-28 |
| KLAXON (TWIST); KLAXON (TWIST R) (K250748) | Klaxon-Mobility GmbH | 2025-04-11 |
| Electric Wheelchair (LW01301A07) (K250366) | Anhui Longway Medical Technology Co., Ltd. | 2025-04-08 |
| Powered wheelchair (mobility robot) (M4, M4U) (K242358) | Xsto Co., Ltd. | 2025-04-03 |
| Power Wheelchair (YH-E6011,YH-E6013A) (K250134) | Ningbo Youhuan Automation Technology Co., Ltd. | 2025-03-26 |
| Electrically powered wheelchair (K244003) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-03-26 |
| Portable Wheelchair (K243970) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-03-07 |
| Handbike Batec Electric (K241159) | Batec Mobility, S.L. | 2025-03-07 |
| Electrically Powered Wheelchair (K243961) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 |
| Electrically Powered Wheelchair (K243962) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 |
| Electric Wheelchair (YE200) (K241641) | Shenzhen Yattll Industry Co., Ltd. | 2025-01-11 |
| Klaxon (Twist); Klaxon (Twist R) (K240267) | Klaxon Mobility GmbH | 2025-01-10 |
| Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) (K242448) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-01-02 |
| Power Wheelchair (D10, D12, D15, D17, D20, D37) (K242468) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-31 |
| Electric Wheelchair (MODEL H) (K242989) | Nanjing E-Take Medical Apparatus Co., Ltd. | 2024-12-31 |
| Power Wheelchair (K242252) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-27 |
| Electric Wheelchair (HC820N) (K243440) | Yongkang Hengyi Vehicle Co., Ltd. | 2024-12-19 |
| Empulse M90 (K242327) | Concourse Assistive Technology Pty, Ltd. | 2024-12-10 |
| Power wheelchair (K242308) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-11-27 |
| Electric Wheelchair (KR8803) (K241588) | Zhejiang Kairui Medical Device Co., Ltd. | 2024-11-25 |
| Powered Wheelchair (NXN20-209) (K241529) | Zhejiang Nysin Medical Co., Ltd. | 2024-11-22 |
| Powered Wheelchair (NXN20-208, NXN20-211) (K241603) | Zhejiang Nysin Medical Co., Ltd. | 2024-11-20 |
| Power wheelchair (K242402) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-11-18 |
| Power Wheelchair (W5538) (K242471) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-11-18 |
| Electric wheelchair (KR-8807) (K242791) | Zhejiang Kairui Medical Device Co., Ltd. | 2024-11-12 |
| Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) (K242430) | Soul Mobility | 2024-11-12 |
| Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) (K241189) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. | 2024-10-29 |
| Electrically powered wheelchair (HP202) (K241337) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-17 |
| Electrically powered wheelchair (K241632) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-16 |
| Power Wheelchair (JJW-6001) (K240563) | ZheJiang J&J Mobility Co., Ltd. | 2024-10-08 |
| Power Wheelchair (K241854) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-10-04 |
| Electric wheelchair (YHWL002, YHWL003) (K240331) | Yongkang Youha Electric Appliance Co., Ltd. | 2024-10-01 |
| Power Wheelchair (YH-E7007) (K240638) | Ningbo Youhuan Automation Technology Co., Ltd. | 2024-09-16 |
| Powered Wheelchair (NXN20-205, NXN20-205M) (K241379) | Zhejiang Nysin Medical Co., Ltd. | 2024-09-16 |
| Electric wheelchair (C001) (K242136) | Zhejiang Hfizer Medical Equipment Co., Ltd. | 2024-09-12 |
| Electric wheelchair (W3902) (K241723) | Zhejiang Richall Medical Technology Co., Ltd. | 2024-09-05 |
| Electric wheelchair (N3901) (K241721) | Zhejiang Richall Medical Technology Co., Ltd. | 2024-09-05 |
| Navigator (FMNVG15); Navigator XL (FMNVX06) (K240105) | Forcemech International, LLC | 2024-08-29 |
| Electric wheelchair (S7018) (K240270) | Guangdong Prestige Technology Company Limited | 2024-08-27 |
| Power wheelchair (N6101) (K241686) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 2024-08-13 |
| Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) (K240079) | Suzhou Ideal Medical Co., Ltd. | 2024-08-09 |
| Electric Wheelchair (JLE-W01A-2023) (K240255) | Zhejiang Jianrui Technology Company Limited | 2024-08-07 |
| Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) (K240339) | Shanghai Bangbang Robotics Co., Ltd. | 2024-07-22 |
| Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) (K241463) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2024-07-18 |
| Electric Wheelchair (YFWB-63) (K241154) | If Health (Xiamen) Intelligent Technology Co.,Ltd | 2024-06-28 |
| Electric wheelchair (K240673) | Zhejiang Hfizer Medical Equipment Co., Ltd. | 2024-06-20 |
| Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) (K240913) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd | 2024-05-31 |
| Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F) (K240329) | Yongkang Youha Electric Appliance Co., Ltd. | 2024-03-25 |
| XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) (K233877) | Magic Mobility | 2024-03-04 |
| Power wheelchair (Model: JMPW-01W) (K232783) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2024-01-19 |
| Velox Power Chair (K231315) | Velox Manufacturing, Inc. | 2024-01-12 |
| Power Wheelchair (N5909) (K230964) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-12-13 |
| Power Wheelchair, W5521 (K231508) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-11-09 |
| Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 (K231868) | Shanghai Bangbang Robotics Co., Ltd. | 2023-10-31 |
| Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) (K232193) | Yurob Rehabilitation Medical Co., Ltd. | 2023-09-22 |
| Power wheelchair (Model:BC-EA8000) (K232121) | Ningbo Baichen Medical Devices Co., Ltd. | 2023-09-15 |
| Ki Power Tilt System (K201869) | Ki Mobility, LLC | 2023-09-05 |
| AMP by Method Mobility, AMP Plus (or +) by Method Mobility (K231032) | Method Mobility | 2023-05-10 |
| Electric Wheelchair (K223393) | Shanghai Bangbang Robotics Co., Ltd. | 2023-03-16 |
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