FDA 510(k)

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

Número K: K250475 · 2025-05-27

RequerenteNingbo Baichen Medical Devices Co., Ltd.

Data da decisão2025-05-27

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Ningbo Baichen Medical Devices Co., Ltd.. The 510(k) number is K250475.

When did Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) receive FDA 510(k) clearance?

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

Who is the listed applicant for Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)?

The FDA 510(k) record lists Ningbo Baichen Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Outros registros que listam Ningbo Baichen Medical Devices Co., Ltd. como candidato(a)

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Fonte oficial

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