FDA 510(k)

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Número K: K230829 · 2023-04-26

RequerenteChongqing Rob Linka Science and Technology Co., Ltd.

Data da decisão2023-04-26

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K230829. 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 TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K230829.

When did TENS7000 Rechargeable (Model:TENS7000 Rechargeable) receive FDA 510(k) clearance?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) received FDA 510(k) clearance on 2023-04-26, under 510(k) number K230829.

Who is the listed applicant for TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

The FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable) 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 Chongqing Rob Linka Science and Technology Co., Ltd. como candidato(a)

K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

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.