FDA 510(k)

电磁刺激器设备（型号EM Contouring和Tesla Duet）

K号: K231318 · 2023-07-07

决定日期2023-07-07

产品代码NGX

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决定实质等同

器械摘要

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K231318. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K231318.

When did Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) receive FDA 510(k) clearance?

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) received FDA 510(k) clearance on 2023-07-07, under 510(k) number K231318.

Who is the listed applicant for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

The FDA 510(k) record lists Beijing Adss Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)?

The FDA product code for Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) is NGX.

列明Beijing Adss Development 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。

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官方来源

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