FDA 510(k)

XT 시리즈 전동 휠체어 (XT2), XT 시리즈 전동 휠체어 (XT4)

K-번호: K233877 · 2024-03-04

결정일2024-03-04

제품 코드ITI

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

결정대체적으로 동일

기기 요약

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is the device name listed in this FDA 510(k) record. The listed applicant is Magic Mobility. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K233877. 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 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Magic Mobility. The 510(k) number is K233877.

When did XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) receive FDA 510(k) clearance?

XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) received FDA 510(k) clearance on 2024-03-04, under 510(k) number K233877.

Who is the listed applicant for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

The FDA 510(k) record lists Magic Mobility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)?

The FDA product code for XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) is ITI.

Magic Mobility를 신청인으로 등재한 기타 기록

K213090프론티어 시리즈 전동轮椅 K211574극한 X8 K203083마지크 360 파워워치어

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