FDA 510(k)

RelieforMe TENS/EMS Device Model UPK-GE01

Número K: K192733 · 2019-12-23

Data da decisão2019-12-23

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

RelieforMe TENS/EMS Device Model UPK-GE01 is the device name listed in this FDA 510(k) record. The listed applicant is Umeheal , Ltd.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K192733. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RelieforMe TENS/EMS Device Model UPK-GE01?

RelieforMe TENS/EMS Device Model UPK-GE01 is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Umeheal , Ltd.. The 510(k) number is K192733.

When did RelieforMe TENS/EMS Device Model UPK-GE01 receive FDA 510(k) clearance?

RelieforMe TENS/EMS Device Model UPK-GE01 received FDA 510(k) clearance on 2019-12-23, under 510(k) number K192733.

Who is the listed applicant for RelieforMe TENS/EMS Device Model UPK-GE01?

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

What is the FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01?

The FDA product code for RelieforMe TENS/EMS Device Model UPK-GE01 is IPF.

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