FDA 510(k)

Heat StimPlus

Número K: K212918 · 2021-12-13

Data da decisão2021-12-13

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Heat StimPlus is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212918. 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 Heat StimPlus?

Heat StimPlus is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Famidoc Technology Co., Ltd.. The 510(k) number is K212918.

When did Heat StimPlus receive FDA 510(k) clearance?

Heat StimPlus received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212918.

Who is the listed applicant for Heat StimPlus?

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

What is the FDA product code for Heat StimPlus?

The FDA product code for Heat StimPlus is NUH.

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