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FDA PRODUCT CODE · CLASS II

ITI — 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).

DEVICE CLASS
Class II
REGULATION
21 CFR 890.3860
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
73
510(K)/PMA CLEARANCES
510k: 73
0
RECALL ENTRIES

Recent clearances

K261149Zhejiang Lumbre Electric Appliance Co., Ltd. · 510k2026-07-10
K261396Ningbo Resshidi Medical Devices Co., Ltd. · 510k2026-07-08
K261164Yongkang Ruihe Metal Product Co., Ltd. · 510k2026-07-07
K260937Shanghai Waylong Intelligent Technology Co.,Ltd · 510k2026-06-24
K253812Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 510k2026-06-18
K260335Zhongshan Sulenz Intelligent Technology Co., Ltd. · 510k2026-06-15
K261175Whill, Inc. · 510k2026-06-12
K260056Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 510k2026-06-05

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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