FDA 510(k)

Electronic Pulse Stimulator

Número K: K160508 · 2016-11-21

RequerenteBeijing Choice Electronic Technololgy Co., Ltd.

Data da decisão2016-11-21

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electronic Pulse Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K160508. 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 Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. The 510(k) number is K160508.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160508.

Who is the listed applicant for Electronic Pulse Stimulator?

The FDA 510(k) record lists Beijing Choice Electronic Technololgy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.