Class Class II

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (K250475)

K250475 2025-05-27 Traditional
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Description

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) by Ningbo Baichen Medical Devices Co., Ltd., an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250475
Clearance Date2025-05-27
Clearance TypeTraditional
Product CodeITI
Regulation Number890.3860

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Predicate lineage for K250475

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) (K250475) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K242471Power Wheelchair (W5538)Zhejiang Innuovo Rehabilitation Dev...2024

Trace the full predicate network for K250475

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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