FDA 510(k)

GIM-STIM OTC TENS/EMS System

N.º K: K190988 · 2019-08-16

Fecha de decisión2019-08-16

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

GIM-STIM OTC TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K190988. 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 GIM-STIM OTC TENS/EMS System?

GIM-STIM OTC TENS/EMS System is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K190988.

When did GIM-STIM OTC TENS/EMS System receive FDA 510(k) clearance?

GIM-STIM OTC TENS/EMS System received FDA 510(k) clearance on 2019-08-16, under 510(k) number K190988.

Who is the listed applicant for GIM-STIM OTC TENS/EMS System?

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

What is the FDA product code for GIM-STIM OTC TENS/EMS System?

The FDA product code for GIM-STIM OTC TENS/EMS System is NUH.

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Dispositivos relacionados (Código: NUH)

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Fuente oficial

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