FDA 510(k)

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

Número K: K213788 · 2022-05-06

RequerenteDongguan Bohuikang Technology Co.,Ltd

Data da decisão2022-05-06

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Bohuikang Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213788. 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 TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Dongguan Bohuikang Technology Co.,Ltd. The 510(k) number is K213788.

When did TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) receive FDA 510(k) clearance?

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213788.

Who is the listed applicant for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

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

What is the FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)?

The FDA product code for TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) is NUH.

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Dispositivos Relacionados (Código: NUH)

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