FDA 510(k)

Li-Battery powered OTC TENS/EMS Combination Stimulator

Número K: K201335 · 2020-10-24

RequerenteEveryway Medical Instruments Co.,Ltd

Data da decisão2020-10-24

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Li-Battery powered OTC TENS/EMS Combination Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-10-24 under 510(k) number K201335. 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 Li-Battery powered OTC TENS/EMS Combination Stimulator?

Li-Battery powered OTC TENS/EMS Combination Stimulator is a medical device that received FDA 510(k) clearance on 2020-10-24. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K201335.

When did Li-Battery powered OTC TENS/EMS Combination Stimulator receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS Combination Stimulator received FDA 510(k) clearance on 2020-10-24, under 510(k) number K201335.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Li-Battery powered OTC TENS/EMS Combination Stimulator?

The FDA product code for Li-Battery powered OTC TENS/EMS Combination 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

Outros registros que listam Everyway Medical Instruments Co.,Ltd como candidato(a)

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 K222488Everyway Analog OTC TENS K213116Everyway Incontinence Stimulation System K202849Everyway Analog OTC TENS, model N103A/N302 K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

Ver todos os 13 dispositivos →

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.