FDA 510(k)

VitalStim(R) Plus 电疗系统

K号: K153224 · 2016-02-17

决定日期2016-02-17

产品代码IPF

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

VitalStim(R) Plus Electrotherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Djo, LLC. It received FDA 510(k) clearance on 2016-02-17 under 510(k) number K153224. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VitalStim(R) Plus Electrotherapy System?

VitalStim(R) Plus Electrotherapy System is a medical device that received FDA 510(k) clearance on 2016-02-17. The listed applicant is Djo, LLC. The 510(k) number is K153224.

When did VitalStim(R) Plus Electrotherapy System receive FDA 510(k) clearance?

VitalStim(R) Plus Electrotherapy System received FDA 510(k) clearance on 2016-02-17, under 510(k) number K153224.

Who is the listed applicant for VitalStim(R) Plus Electrotherapy System?

The FDA 510(k) record lists Djo, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalStim(R) Plus Electrotherapy System?

The FDA product code for VitalStim(R) Plus Electrotherapy System is IPF.

列明Djo, LLC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。

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