FDA 510(k)

ThermaCare Quick Therapy TENS

Número K: K181102 · 2018-09-15

Data da decisão2018-09-15

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ThermaCare Quick Therapy TENS is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 2018-09-15 under 510(k) number K181102. 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 ThermaCare Quick Therapy TENS?

ThermaCare Quick Therapy TENS is a medical device that received FDA 510(k) clearance on 2018-09-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K181102.

When did ThermaCare Quick Therapy TENS receive FDA 510(k) clearance?

ThermaCare Quick Therapy TENS received FDA 510(k) clearance on 2018-09-15, under 510(k) number K181102.

Who is the listed applicant for ThermaCare Quick Therapy TENS?

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

What is the FDA product code for ThermaCare Quick Therapy TENS?

The FDA product code for ThermaCare Quick Therapy TENS is NUH.

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