FDA 510(k)

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

Número K: K163166 · 2017-08-11

Data da decisão2017-08-11

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is the device name listed in this FDA 510(k) record. The listed applicant is Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K163166. 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 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Easywell Biomedicals, Inc.. The 510(k) number is K163166.

When did EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only receive FDA 510(k) clearance?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only received FDA 510(k) clearance on 2017-08-11, under 510(k) number K163166.

Who is the listed applicant for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

The FDA 510(k) record lists Easywell Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

The FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is NUH.

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