FDA 510(k)

StimOnTM Pain Relief System (GM2439)

Número K: K213802 · 2022-08-26

Data da decisão2022-08-26

Código do produtoGZJ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StimOnTM Pain Relief System (GM2439) is the device name listed in this FDA 510(k) record. The listed applicant is Gimer Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K213802. 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 StimOnTM Pain Relief System (GM2439)?

StimOnTM Pain Relief System (GM2439) is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Gimer Medical Co., Ltd.. The 510(k) number is K213802.

When did StimOnTM Pain Relief System (GM2439) receive FDA 510(k) clearance?

StimOnTM Pain Relief System (GM2439) received FDA 510(k) clearance on 2022-08-26, under 510(k) number K213802.

Who is the listed applicant for StimOnTM Pain Relief System (GM2439)?

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

What is the FDA product code for StimOnTM Pain Relief System (GM2439)?

The FDA product code for StimOnTM Pain Relief System (GM2439) is GZJ.

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