FDA 510(k)

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

Número K: K221384 · 2022-06-11

Data da decisão2022-06-11

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 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 2022-06-11 under 510(k) number K221384. 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 Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is a medical device that received FDA 510(k) clearance on 2022-06-11. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K221384.

When did Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 receive FDA 510(k) clearance?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 received FDA 510(k) clearance on 2022-06-11, under 510(k) number K221384.

Who is the listed applicant for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

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 Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

The FDA product code for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is NUH.

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Outros registros que listam Hivox Biotek, Inc. como candidato(a)

K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)K242815POCKET TENS (EP-300)K232675Heating Tens, FT-615 K223308HEATING TENS/EMS, FT-810R K211403HIVOX OTC Electrical Stimulator, FT610-B K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

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Dispositivos Relacionados (Código: NUH)

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Fonte oficial

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