FDA 510(k)

OGYILI TENS/NMES Stimulator

Número K: K201431 · 2020-11-09

RequerenteGongguan Tutamen Metalwork Co., Ltd.

Data da decisão2020-11-09

Código do produtoGZJ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OGYILI TENS/NMES Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Gongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K201431. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OGYILI TENS/NMES Stimulator?

OGYILI TENS/NMES Stimulator is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Gongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K201431.

When did OGYILI TENS/NMES Stimulator receive FDA 510(k) clearance?

OGYILI TENS/NMES Stimulator received FDA 510(k) clearance on 2020-11-09, under 510(k) number K201431.

Who is the listed applicant for OGYILI TENS/NMES Stimulator?

The FDA 510(k) record lists Gongguan Tutamen Metalwork Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OGYILI TENS/NMES Stimulator?

The FDA product code for OGYILI TENS/NMES Stimulator is GZJ.

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