FDA 510(k)

BionicGym Powered Muscle Stimulator

Número K: K182794 · 2019-07-18

Data da decisão2019-07-18

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

BionicGym Powered Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Medical Currents, Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K182794. 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 BionicGym Powered Muscle Stimulator?

BionicGym Powered Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Medical Currents, Ltd.. The 510(k) number is K182794.

When did BionicGym Powered Muscle Stimulator receive FDA 510(k) clearance?

BionicGym Powered Muscle Stimulator received FDA 510(k) clearance on 2019-07-18, under 510(k) number K182794.

Who is the listed applicant for BionicGym Powered Muscle Stimulator?

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

What is the FDA product code for BionicGym Powered Muscle Stimulator?

The FDA product code for BionicGym Powered Muscle Stimulator is NGX.

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Fonte oficial

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