FDA 510(k)

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

Номер K: K213788 · 2022-05-06

ЗаявительDongguan Bohuikang Technology Co.,Ltd

Дата решения2022-05-06

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Официальный источник

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