FDA 510(k)

代步车（空气碳）

K号: K260717 · 2026-05-20

申请人Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

决定日期2026-05-20

产品代码INI

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Mobility Scooter (Air Carbon) 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 2026-05-20 under 510(k) number K260717. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobility Scooter (Air Carbon)?

Mobility Scooter (Air Carbon) is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. The 510(k) number is K260717.

When did Mobility Scooter (Air Carbon) receive FDA 510(k) clearance?

Mobility Scooter (Air Carbon) received FDA 510(k) clearance on 2026-05-20, under 510(k) number K260717.

Who is the listed applicant for Mobility Scooter (Air Carbon)?

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 Carbon)?

The FDA product code for Mobility Scooter (Air Carbon) is INI.

列明Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253075电动轮椅（Air Classic）；电动轮椅（Air Traveller）；电动轮椅（Air Traveller2.0）K231472代步车（S1 SPORT, S1 PLUS, MAX SPORT）

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。