← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

IORWheelchair, Mechanical

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

DEVICE CLASS
Class I
REGULATION
21 CFR 890.3850
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
ImplantLife-sustainingGMP-exemptThird-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K261076GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 510k2026-06-22
K261075GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · 510k2026-06-22
K260849Rehasense USA, Inc. · 510k2026-06-11
K260642Anhui Longway Medical Technology Co., Ltd. · 510k2026-06-02
K260295Motion Composites · 510k2026-05-28
K254141Guangdong Dayang Medical Technology Co., Ltd. · 510k2026-05-21
K260121Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 510k2026-04-28
K260319Zhenjiang Assure Medical Equipment Co., Ltd. · 510k2026-03-31

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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