FDA 510(k)

이동식스쿠터 (에어 클래식); 이동식스쿠터 (에어 트래블러); 이동식스쿠터 (에어 트래블러 2.0)

K-번호: K253075 · 2026-01-09

신청자Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

결정일2026-01-09

제품 코드INI

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

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K253075. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)?

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. The 510(k) number is K253075.

When did Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) receive FDA 510(k) clearance?

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) received FDA 510(k) clearance on 2026-01-09, under 510(k) number K253075.

Who is the listed applicant for Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)?

The FDA 510(k) record lists Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)?

The FDA product code for Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) is INI.

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K260717이동식 스쿠터 (에어 카본)K231472이동식 스쿠터 (S1 SPORT, S1 PLUS, MAX SPORT)

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