FDA 510(k)

Electric Wheelchair (DY611A-2, DY612A-1)

K-번호: K261149 · 2026-07-10

신청자Zhejiang Lumbre Electric Appliance Co., Ltd.

결정일2026-07-10

제품 코드ITI

자문 위원회PM

결정Substantially Equivalent

기기 요약

Electric Wheelchair (DY611A-2, DY612A-1) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lumbre Electric Appliance Co., Ltd.. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261149. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Electric Wheelchair (DY611A-2, DY612A-1)?

Electric Wheelchair (DY611A-2, DY612A-1) is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Zhejiang Lumbre Electric Appliance Co., Ltd.. The 510(k) number is K261149.

When did Electric Wheelchair (DY611A-2, DY612A-1) receive FDA 510(k) clearance?

Electric Wheelchair (DY611A-2, DY612A-1) received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261149.

Who is the listed applicant for Electric Wheelchair (DY611A-2, DY612A-1)?

The FDA 510(k) record lists Zhejiang Lumbre Electric Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (DY611A-2, DY612A-1)?

The FDA product code for Electric Wheelchair (DY611A-2, DY612A-1) is ITI.

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Electric Wheelchair (DY611A-2, DY612A-1)

기기 요약

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관련 임상시험

관련 기기 (코드: ITI)

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