FDA 510(k)

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

N.º K: K260425 · 2026-06-16

Fecha de decisión2026-06-16

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) 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 2026-06-16 under 510(k) number K260425. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K260425.

When did TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) receive FDA 510(k) clearance?

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260425.

Who is the listed applicant for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

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 TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

The FDA product code for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) is NUH.

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Otros registros que enlistan a Hivox Biotek, Inc. como solicitante

K242815POCKET TENS (EP-300)K232675Heating Tens, FT-615 K223308HEATING TENS/EMS, FT-810R K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 K211403HIVOX OTC Electrical Stimulator, FT610-B K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

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Fuente oficial

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