FDA 510(k)

电动轮椅 (HP202)

K号: K241337 · 2024-10-17

申请人Kunshan Hi-Fortune Health Products Co., Ltd.

决定日期2024-10-17

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

Electrically powered wheelchair (HP202) is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K241337. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Electrically powered wheelchair (HP202)?

Electrically powered wheelchair (HP202) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K241337.

When did Electrically powered wheelchair (HP202) receive FDA 510(k) clearance?

Electrically powered wheelchair (HP202) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K241337.

Who is the listed applicant for Electrically powered wheelchair (HP202)?

The FDA 510(k) record lists Kunshan Hi-Fortune Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrically powered wheelchair (HP202)?

The FDA product code for Electrically powered wheelchair (HP202) is ITI.

列明Kunshan Hi-Fortune Health Products 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。

K244003电动轮椅 K243962电动轮椅 K243961电动轮椅 K241632电动轮椅 K212503HP458E 电动轮椅 K211647HP358EA 电动轮椅

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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。