FDA 510(k)

便携式折叠电动轮椅（型号：DC01）

K号: K212092 · 2022-05-06

申请人Anhui Jbh Medical Apparatus Co., Ltd.

决定日期2022-05-06

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

Portable Folding Electric Wheelchair (Model: DC01) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Jbh Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212092. 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 Portable Folding Electric Wheelchair (Model: DC01)?

Portable Folding Electric Wheelchair (Model: DC01) is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Anhui Jbh Medical Apparatus Co., Ltd.. The 510(k) number is K212092.

When did Portable Folding Electric Wheelchair (Model: DC01) receive FDA 510(k) clearance?

Portable Folding Electric Wheelchair (Model: DC01) received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212092.

Who is the listed applicant for Portable Folding Electric Wheelchair (Model: DC01)?

FDA 510(k)记录将安徽Jbh医疗设备股份有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Portable Folding Electric Wheelchair (Model: DC01)?

The FDA product code for Portable Folding Electric Wheelchair (Model: DC01) is ITI.

列明Anhui Jbh Medical Apparatus 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。

K261078电动滑板车（FNS01，FNS03）K261859电动滑板车（FDB08，FDB08A，FDB12）K251606Power Wheelchair（D26）K241374手动轮椅（S002，S004，S005，S006，S007，S008，S009）K242448Power Wheelchair（D03，D05，D06，D09，D11，D16，D22，D23，D26，D36）K242468Power Wheelchair（D10，D12，D15，D17，D20，D37）

查看所有 11 个设备 →

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。