FDA 510(k)

Power Wheelchair（D03，D05，D06，D09，D11，D16，D22，D23，D26，D36）

K号: K242448 · 2025-01-02

申请人Anhui Jbh Medical Apparatus Co., Ltd.

决定日期2025-01-02

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

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) 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 2025-01-02 under 510(k) number K242448. 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 Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)?

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Anhui Jbh Medical Apparatus Co., Ltd.. The 510(k) number is K242448.

When did Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) receive FDA 510(k) clearance?

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K242448.

Who is the listed applicant for Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)?

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 Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)?

The FDA product code for Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) 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）K242468Power Wheelchair（D10，D12，D15，D17，D20，D37）K242252Power Wheelchair

查看所有 11 个设备 →

官方来源

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