FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (9029SCM)

Número K: K240292 · 2024-03-25

RequerenteHong Kong Etech Groups Limited

Data da decisão2024-03-25

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcutaneous Electrical Nerve Stimulator (9029SCM) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Kong Etech Groups Limited. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K240292. 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 (9029SCM)?

Transcutaneous Electrical Nerve Stimulator (9029SCM) is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Hong Kong Etech Groups Limited. The 510(k) number is K240292.

When did Transcutaneous Electrical Nerve Stimulator (9029SCM) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (9029SCM) received FDA 510(k) clearance on 2024-03-25, under 510(k) number K240292.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (9029SCM)?

The FDA 510(k) record lists Hong Kong Etech Groups Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (9029SCM)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (9029SCM) is NUH.

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