FDA 510(k)

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

Número K: K231318 · 2023-07-07

RequerenteBeijing Adss Development Co., Ltd.

Data da decisão2023-07-07

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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