ITI · Wheelchair, Powered · Chrysalis Intelligence

Device class

Class II

Regulation 890.3860

Total clearances

140

2020-01-02 → 2026-09-23

Last 12 months

Unique sponsors

Definition

What is Wheelchair, Powered

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).

Classification details

Medical specialty

Physical Medicine

Review panel

Regulation number

890.3860

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
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	9	3	2026-06-18
Kunshan Hi-Fortune Health Products Co., Ltd.	8	0	2025-03-26
Anhui Jbh Medical Apparatus Co., Ltd.	6	0	2025-06-25
Shanghai Bangbang Robotics Co., Ltd.	4	1	2026-01-15
Magic Mobility	4	0	2024-03-04
Foshan Dahao Medical Technology Co., Ltd.	4	3	2026-03-27
Dongguan Prestige Sporting Goods Co., Ltd.	4	0	2021-04-16
Zhejiang Nysin Medical Co., Ltd.	3	0	2024-11-22
Whill, Inc.	3	1	2026-06-12
Alber GmbH	3	0	2022-05-24
Zhejiang Zhonglei Medical Technology Co. , Ltd.	3	0	2024-11-27
Ningbo Baichen Medical Devices Co., Ltd.	2	0	2025-05-27
Zhejiang Richall Medical Technology Co., Ltd.	2	0	2024-09-05
Yongkang Youha Electric Appliance Co., Ltd.	2	0	2024-10-01
Jiangsu Intco Medical Products Co., Ltd.	2	1	2026-05-13
Suzhou Master Machinery Manufacturing Co.,Ltd	2	1	2026-03-04
Zhejiang Kairui Medical Device Co., Ltd.	2	0	2024-11-25
Zhejiang Hfizer Medical Equipment Co., Ltd.	2	0	2024-09-12
Yongkang Hengyi Vehicle Co., Ltd.	2	1	2026-09-08
Klaxon Mobility GmbH	2	0	2025-01-10
Yamaha Motor Co., Ltd.	2	1	2026-03-19
Beijing OrionStar Technology Co., Ltd.	2	2	2026-09-08
Yurob Rehabilitation Medical Co., Ltd.	2	1	2026-03-27
Ningbo Youhuan Automation Technology Co., Ltd.	2	0	2025-03-26
ZheJiang J&J Mobility Co., Ltd.	2	1	2026-03-20

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
E1190	HCPCS	Amputee wheelchair, detachable arms (desk or full length) swing away detachable elevating legrests ✓ CMS-verified description	High	HCPCS code for powered wheelchair, standard
E1200	HCPCS	Amputee wheelchair, fixed full length arms, swing away detachable footrest ✓ CMS-verified description	Medium	Alternative HCPCS for motorized wheelchair with programmed control

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-23	K262582	Suzhou Green Pine Medical Co., Ltd.	Electric wheelchair (GP100)
2026-09-16	K262054	Yongkang Joymax Medical Technology Co., Ltd.	Electric Wheelchair
2026-09-08	K260229	Yongkang Hengyi Vehicle Co., Ltd.	Electric wheelchair (HC819N, HC830N, HC831N)
2026-09-08	K260053	Beijing OrionStar Technology Co., Ltd.	Power Wheelchair (OS-R-M01I)
2026-08-21	K261354	Foshan Sowell Medical Technology Co., Ltd.	Electric wheelchair (D03)
2026-07-10	K261149	Zhejiang Lumbre Electric Appliance Co., Ltd.	Electric Wheelchair (DY611A-2, DY612A-1)
2026-07-08	K261396	Ningbo Resshidi Medical Devices Co., Ltd.	Electric Wheelchair
2026-07-07	K261164	Yongkang Ruihe Metal Product Co., Ltd.	Electric wheelchair (XW-LY007 )
2026-06-24	K260937	Shanghai Waylong Intelligent Technology Co.,Ltd	Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
2026-06-18	K253812	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	Power Wheelchair (W5915B, W5915C, W5915D)
2026-06-15	K260335	Zhongshan Sulenz Intelligent Technology Co., Ltd.	Electric Wheelchair (S500-6)
2026-06-12	K261175	Whill, Inc.	WHILL (WHILL Model C2)
2026-06-05	K260056	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	Power Wheelchair (N5515A, N5516, N5517A, N5519)
2026-06-03	K260373	Jiangsu Yveelt Medical Equipment Co., Ltd.	Electric Wheelchair (DF506)
2026-05-13	K253241	Jiangsu Intco Medical Products Co., Ltd.	Electric Wheelchair (Y207BL)
2026-04-20	K253806	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	Power Wheelchair (N5919 series)
2026-04-07	K253952	Beijing OrionStar Technology Co., Ltd.	Power Wheelchair (OS-R-M01S)
2026-04-03	K253340	Zhongshan A&J Medical Equipment Co., Ltd.	Electric Wheelchair (AL-208S-063)
2026-03-27	K254206	Ningbo Zhishan Medical Technology Co., Ltd.	Power wheelchair (ZS-EW8026)
2026-03-27	K253980	Yurob Rehabilitation Medical Co., Ltd.	Electrically Powered Wheelchair (Model YC-01)
2026-03-27	K253307	Foshan Dahao Medical Technology Co., Ltd.	Electric wheelchair
2026-03-24	K254012	Nanjing CareMoving Rehabilitation Equipment Co.,Ltd	Electric Wheelchair (E201)
2026-03-20	K253849	ZheJiang J&J Mobility Co., Ltd.	Electric wheelchair (JJW-7002, JJW-7003)
2026-03-19	K252101	Yamaha Motor Co., Ltd.	JWG-1
2026-03-04	K253870	Suzhou Master Machinery Manufacturing Co.,Ltd	Electric Wheelchair (MP148)