FDA 510(k)

Dispositivo de Tonificação Corporal AK

Número K: K152420 · 2016-12-01

Data da decisão2016-12-01

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

AK Body Toning Device is the device name listed in this FDA 510(k) record. The listed applicant is Ak Beauty Enterprises, LLC. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K152420. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AK Body Toning Device?

AK Body Toning Device is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Ak Beauty Enterprises, LLC. The 510(k) number is K152420.

When did AK Body Toning Device receive FDA 510(k) clearance?

AK Body Toning Device received FDA 510(k) clearance on 2016-12-01, under 510(k) number K152420.

Who is the listed applicant for AK Body Toning Device?

The FDA 510(k) record lists Ak Beauty Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK Body Toning Device?

The FDA product code for AK Body Toning Device is NGX.

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