FDA 510(k)

Vibrance Pelvic Trainer

Número K: K162689 · 2017-06-08

Data da decisão2017-06-08

Código do produtoHIR

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vibrance Pelvic Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Bioinfinity (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162689. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vibrance Pelvic Trainer?

Vibrance Pelvic Trainer is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Bioinfinity (M) Sdn. Bhd.. The 510(k) number is K162689.

When did Vibrance Pelvic Trainer receive FDA 510(k) clearance?

Vibrance Pelvic Trainer received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162689.

Who is the listed applicant for Vibrance Pelvic Trainer?

The FDA 510(k) record lists Bioinfinity (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vibrance Pelvic Trainer?

The FDA product code for Vibrance Pelvic Trainer is HIR.

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