ITI · Class II · 21 CFR 890.3860

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 Anhui Jbh Medical Apparatus Co., Ltd., Invacare Corporation and Kunshan Hi-Fortune Health Products Co., Ltd..

575
Total
575
Cleared
121d
Avg days
1978
Since
575 devices
25–48 of 575
Cleared Jul 02, 2025
Power Wheelchair (MOB1107)
K250729
Vive Health, LLC
Physical Medicine · 113d
Cleared Jul 02, 2025
Electric Wheelchair (HG-630)
K251285
Zhejiang Automwheel Tech Co., Ltd.
Physical Medicine · 68d
Cleared Jun 25, 2025
Power Wheelchair (D26)
K251606
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 29d
Cleared Jun 20, 2025
ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
K251248
Jinhua Qidian Vehicle Co., Ltd.
Physical Medicine · 58d
Cleared May 27, 2025
Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
K250475
Ningbo Baichen Medical Devices Co., Ltd.
Physical Medicine · 97d
Cleared May 09, 2025
Electric Wheelchair (F309)
K250758
Changshu Pingfang Wheelchair Co., Ltd.
Physical Medicine · 57d
Cleared May 08, 2025
eFOLDi Navigator Powerchair (STPC-A)
K243110
Suntech UK , Ltd.
Physical Medicine · 220d
Cleared Apr 28, 2025
Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
K250158
Zhe Jiang Cleisman Industry and Trade Co.,Ltd
Physical Medicine · 97d
Cleared Apr 11, 2025
KLAXON (TWIST)
K250748
Klaxon Mobility GmbH
Physical Medicine · 30d
Cleared Apr 08, 2025
Electric Wheelchair (LW01301A07)
K250366
Anhui Longway Medical Technology Co., Ltd.
Physical Medicine · 57d
Cleared Apr 03, 2025
Powered wheelchair (mobility robot) (M4, M4U)
K242358
Xsto Co., Ltd.
Physical Medicine · 238d
Cleared Mar 26, 2025
Electrically powered wheelchair
K244003
Kunshan Hi-Fortune Health Products Co., Ltd.
Physical Medicine · 90d
Cleared Mar 26, 2025
Power Wheelchair (YH-E6011,YH-E6013A)
K250134
Ningbo Youhuan Automation Technology Co., Ltd.
Physical Medicine · 68d
Cleared Mar 07, 2025
Handbike Batec Electric
K241159
Batec Mobility, S.L.
Physical Medicine · 315d
Cleared Mar 07, 2025
Portable Wheelchair
K243970
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 74d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961
Kunshan Hi-Fortune Health Products Co., Ltd.
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962
Kunshan Hi-Fortune Health Products Co., Ltd.
Physical Medicine · 51d
Cleared Jan 11, 2025
Electric Wheelchair (YE200)
K241641
Shenzhen Yattll Industry Co., Ltd.
Physical Medicine · 218d
Cleared Jan 10, 2025
Klaxon (Twist)
K240267
Klaxon Mobility GmbH
Physical Medicine · 345d
Cleared Jan 02, 2025
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
K242448
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 139d
Cleared Dec 31, 2024
Power Wheelchair (D10, D12, D15, D17, D20, D37)
K242468
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 133d
Cleared Dec 31, 2024
Electric Wheelchair (MODEL H)
K242989
Nanjing E-Take Medical Apparatus Co., Ltd.
Physical Medicine · 96d
Cleared Dec 27, 2024
Power Wheelchair
K242252
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 149d
Cleared Dec 19, 2024
Electric Wheelchair (HC820N)
K243440
Yongkang Hengyi Vehicle Co., Ltd.
Physical Medicine · 43d