FDA 510(k)

HIVOX OTC Electrical Stimulator, FT610-B

Número K: K211403 · 2021-10-15

Data da decisão2021-10-15

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

HIVOX OTC Electrical Stimulator, FT610-B is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211403. 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 HIVOX OTC Electrical Stimulator, FT610-B?

HIVOX OTC Electrical Stimulator, FT610-B is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K211403.

When did HIVOX OTC Electrical Stimulator, FT610-B receive FDA 510(k) clearance?

HIVOX OTC Electrical Stimulator, FT610-B received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211403.

Who is the listed applicant for HIVOX OTC Electrical Stimulator, FT610-B?

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

What is the FDA product code for HIVOX OTC Electrical Stimulator, FT610-B?

The FDA product code for HIVOX OTC Electrical Stimulator, FT610-B is NUH.

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