FDA 510(k)

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

N.º K: K181688 · 2018-09-07

SolicitanteShenzhen Roundwhale Technology Co. , Ltd.

Fecha de decisión2018-09-07

Código de productoIPF

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181688. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K181688.

When did R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator receive FDA 510(k) clearance?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181688.

Who is the listed applicant for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

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

What is the FDA product code for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

The FDA product code for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is IPF.

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Otros registros que enlistan a Shenzhen Roundwhale Technology Co. , Ltd. como solicitante

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Fuente oficial

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