FDA 510(k)

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Número K: K253305 · 2025-12-31

RequerenteShenzhen Jiantuo Electronics Co., Ltd.

Data da decisão2025-12-31

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jiantuo Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K253305. 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 AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Shenzhen Jiantuo Electronics Co., Ltd.. The 510(k) number is K253305.

When did TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) receive FDA 510(k) clearance?

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) received FDA 510(k) clearance on 2025-12-31, under 510(k) number K253305.

Who is the listed applicant for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

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

What is the FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)?

The FDA product code for TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) 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 Shenzhen Jiantuo Electronics Co., Ltd. como candidato(a)

K250360TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)K250053TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

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.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS BackDynapulse Medical

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.