FDA 510(k)

电动轮椅

Q: FDA电动轮椅的产品代码是什么？

FDA电动轮椅的产品代码是ITI。

K号: K220827 · 2022-07-05

申请人Foshan Dahao Medical Technology Co., Ltd.

决定日期2022-07-05

产品代码ITI

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

Electric Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Dahao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-05 under 510(k) number K220827. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是电动轮椅？

Electric Wheelchair is a medical device that received FDA 510(k) clearance on 2022-07-05. The listed applicant is Foshan Dahao Medical Technology Co., Ltd.. The 510(k) number is K220827.

电动轮椅何时获得FDA 510(k)批准？

Electric Wheelchair received FDA 510(k) clearance on 2022-07-05, under 510(k) number K220827.

电动轮椅的申请人名单是谁？

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

FDA电动轮椅的产品代码是什么？

FDA电动轮椅的产品代码是ITI。

列明Foshan Dahao Medical 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。

K253307电动轮椅 K251458电动轮椅（DH01168）K252862电动轮椅（DH01126）

官方来源

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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。