FDA 510(k)

OTC TENS Device, Model PTS-IV

Número K: K161537 · 2016-10-13

RequerenteCounter Scientific Development (Gz), Ltd.

Data da decisão2016-10-13

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OTC TENS Device, Model PTS-IV is the device name listed in this FDA 510(k) record. The listed applicant is Counter Scientific Development (Gz), Ltd.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K161537. 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 OTC TENS Device, Model PTS-IV?

OTC TENS Device, Model PTS-IV is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Counter Scientific Development (Gz), Ltd.. The 510(k) number is K161537.

When did OTC TENS Device, Model PTS-IV receive FDA 510(k) clearance?

OTC TENS Device, Model PTS-IV received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161537.

Who is the listed applicant for OTC TENS Device, Model PTS-IV?

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

What is the FDA product code for OTC TENS Device, Model PTS-IV?

The FDA product code for OTC TENS Device, Model PTS-IV is NUH.

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Dispositivos Relacionados (Código: NUH)

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