FDA 510(k)

Transcutaneous Electrical Nerve Stimulator

Número K: K210223 · 2021-12-15

RequerenteTop-Rank Health Care Co., Ltd.

Data da decisão2021-12-15

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcutaneous Electrical Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210223. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Transcutaneous Electrical Nerve Stimulator?

Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Top-Rank Health Care Co., Ltd.. The 510(k) number is K210223.

When did Transcutaneous Electrical Nerve Stimulator receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210223.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator?

The FDA 510(k) record lists Top-Rank Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator?

The FDA product code for Transcutaneous Electrical Nerve Stimulator is NUH.

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Fonte oficial

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