FDA 510(k)

Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)

K-번호: K232193 · 2023-09-22

신청자Yurob Rehabilitation Medical Co., Ltd.

결정일2023-09-22

제품 코드ITI

자문 위원회PM

결정Substantially Equivalent

기기 요약

Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) is the device name listed in this FDA 510(k) record. The listed applicant is Yurob Rehabilitation Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232193. 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 Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)?

Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Yurob Rehabilitation Medical Co., Ltd.. The 510(k) number is K232193.

When did Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) receive FDA 510(k) clearance?

Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232193.

Who is the listed applicant for Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)?

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

What is the FDA product code for Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)?

The FDA product code for Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) is ITI.

Yurob Rehabilitation Medical Co., Ltd.를 신청인으로 등재한 기타 기록

K253600Scooter (YD-03)K253980Electrically Powered Wheelchair (Model YC-01)

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