FDA 510(k)

Aluminum back folding wheelchair SYIV 100-LQXAL2482-407

K-번호: K213790 · 2022-03-14

신청자Mobility Source Medical Technology Co., Ltd.

결정일2022-03-14

제품 코드IOR

자문 위원회의료장비 규제 텍스트 번역 PM [회사명/제품명]은 FDA(미국 식품의약국)에 등록된 의료장비로, 510(k) 신청을 통해 시장에 출시되었습니다. PMA(Premarket Approval) 신청도 진행 중입니다. 연구 참가자를 모으기 위해 NCT(National Clinical Trial) 번호 [NCT]와 PMID(Publication Medical Identifier) [PMID]를 사용하고 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

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기기 요약

Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 is the device name listed in this FDA 510(k) record. The listed applicant is Mobility Source Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K213790. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aluminum back folding wheelchair SYIV 100-LQXAL2482-407?

Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Mobility Source Medical Technology Co., Ltd.. The 510(k) number is K213790.

When did Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 receive FDA 510(k) clearance?

Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 received FDA 510(k) clearance on 2022-03-14, under 510(k) number K213790.

Who is the listed applicant for Aluminum back folding wheelchair SYIV 100-LQXAL2482-407?

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

What is the FDA product code for Aluminum back folding wheelchair SYIV 100-LQXAL2482-407?

The FDA product code for Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 is IOR.

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Aluminum back folding wheelchair SYIV 100-LQXAL2482-407

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IOR)

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