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FDA 510(k)

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

K-Number: K250475 · 2025-05-27

ApplicantNingbo Baichen Medical Devices Co., Ltd.
Decision Date2025-05-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) is a medical device manufactured by Ningbo Baichen Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-05-27 under approval number K250475. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)?

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Ningbo Baichen Medical Devices Co., Ltd.. The 510(k) number is K250475.

When was Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) approved by the FDA?

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) received FDA 510(k) clearance on 2025-05-27, under approval number K250475.

What company makes Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)?

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) is manufactured by Ningbo Baichen Medical Devices Co., Ltd..

What is the FDA product code for Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)?

The FDA product code for Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) is ITI.

Other Devices by Ningbo Baichen Medical Devices Co., Ltd.

K232121Power wheelchair (Model:BC-EA8000) K252817Mobility Scooter (BC-MS310)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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