FDA Product Code ITI: Wheelchair, Powered
FDA product code ITI covers powered wheelchairs — battery-operated mobility devices for individuals who cannot propel a manual wheelchair.
These devices use an electric motor controlled by a joystick, sip-and-puff switch, or other interface to provide independent mobility for people with spinal cord injury, muscular dystrophy, ALS, and other conditions affecting upper and lower limb function.
ITI devices are Class II medical devices, regulated under 21 CFR 890.3860 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, Kunshan Hi-Fortune Health Products Co., Ltd. and Anhui Jbh Medical Apparatus Co., Ltd..
578
Total
578
Cleared
122d
Avg days
1978
Since
Growing category -
79 submissions in the last 2 years
vs 20 in the prior period
Consistent review times:
130d avg (recent)
FDA 510(k) Cleared Wheelchair, Powered Devices (Product Code ITI)
578 devices
Cleared
Jun 05, 2026
Power Wheelchair (N5515A, N5516, N5517A, N5519)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Physical Medicine
148d
Cleared
Jun 03, 2026
Electric Wheelchair (DF506)
Jiangsu Yveelt Medical Equipment Co., Ltd.
Physical Medicine
118d
Cleared
May 13, 2026
Electric Wheelchair (Y207BL)
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine
226d
Cleared
Apr 20, 2026
Power Wheelchair (N5919 series)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Physical Medicine
143d
Cleared
Apr 07, 2026
Power Wheelchair (OS-R-M01S)
Beijing OrionStar Technology Co., Ltd.
Physical Medicine
118d
Cleared
Apr 03, 2026
Electric Wheelchair (AL-208S-063)
Zhongshan A&J Medical Equipment Co., Ltd.
Physical Medicine
185d
Cleared
Mar 27, 2026
Electric wheelchair
Foshan Dahao Medical Technology Co., Ltd.
Physical Medicine
179d
Cleared
Mar 27, 2026
Electrically Powered Wheelchair (Model YC-01)
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine
105d
Cleared
Mar 27, 2026
Power wheelchair (ZS-EW8026)
Ningbo Zhishan Medical Technology Co., Ltd.
Physical Medicine
88d
Cleared
Mar 24, 2026
Electric Wheelchair (E201)
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
Physical Medicine
99d
Cleared
Mar 20, 2026
Electric wheelchair (JJW-7002, JJW-7003)
ZheJiang J&J Mobility Co., Ltd.
Physical Medicine
108d
Cleared
Mar 19, 2026
JWG-1
Yamaha Motor Co., Ltd.
Physical Medicine
259d
Cleared
Mar 04, 2026
Electric Wheelchair (MP148)
Suzhou Master Machinery Manufacturing Co.,Ltd
Physical Medicine
90d
Cleared
Feb 25, 2026
Electric wheelchair
Zhejiang Yikang Medical Technology Co., Ltd.
Physical Medicine
89d
Cleared
Feb 24, 2026
Electric wheelchair (W1,W3)
Shenzhen Zhimahuaerkai Technology Co., Ltd.
Physical Medicine
92d
Cleared
Feb 17, 2026
Electric Wheelchair (W-A807, W-A807L)
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine
91d
Cleared
Jan 15, 2026
Electric Wheelchair (DH01168)
Foshan Dahao Medical Technology Co., Ltd.
Physical Medicine
248d
Cleared
Jan 15, 2026
Electric Wheelchair (Robooter E80) (BBR-E80-01)
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine
108d
Cleared
Dec 22, 2025
Power wheelchair
Zhenjiang Assure Medical Equipment Co., Ltd.
Physical Medicine
251d
Cleared
Dec 08, 2025
Electric Wheelchair (DH01126)
Foshan Dahao Medical Technology Co., Ltd.
Physical Medicine
90d
Cleared
Dec 05, 2025
Electrically powered wheelchair (KZ301B)
Nanjing Kangni Smart Technology Co., Ltd.
Physical Medicine
119d
Cleared
Nov 12, 2025
Powered Wheelchair (PL001-9001)
Suzhou KD Intelligent Device Co., Ltd.
Physical Medicine
68d
Cleared
Nov 07, 2025
Electric Wheelchair (Rollz Motion Electric 2M)
Rollz International BV
Physical Medicine
234d
Cleared
Nov 03, 2025
Electric wheelchair (NSDS-01)
Hebei Dansong Medical Technology Co., Ltd.
Physical Medicine
70d
About Product Code ITI - Regulatory Context
510(k) Submission Activity
578 total 510(k) submissions under product code ITI since 1978, with 578 receiving FDA clearance (average review time: 122 days).
Submission volume has increased in recent years - 79 submissions in the last 24 months compared to 20 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - ITI Product Code
FDA review times for ITI submissions have been consistent, averaging 130 days recently vs 120 days historically.
ITI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →