FDA 510(k)

Medi-Direct TENS Pen

N.º K: K182671 · 2019-09-21

Fecha de decisión2019-09-21

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medi-Direct TENS Pen is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2019-09-21 under 510(k) number K182671. 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 Medi-Direct TENS Pen?

Medi-Direct TENS Pen is a medical device that received FDA 510(k) clearance on 2019-09-21. The listed applicant is Jkh USA, LLC. The 510(k) number is K182671.

When did Medi-Direct TENS Pen receive FDA 510(k) clearance?

Medi-Direct TENS Pen received FDA 510(k) clearance on 2019-09-21, under 510(k) number K182671.

Who is the listed applicant for Medi-Direct TENS Pen?

The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medi-Direct TENS Pen?

The FDA product code for Medi-Direct TENS Pen is NUH.

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Fuente oficial

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