FDA 510(k)

EMS/TENS Massager Device

Número K: K233040 · 2024-02-12

RequerenteShenzhen Imdk Medical Technology Co., Ltd.

Data da decisão2024-02-12

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMS/TENS Massager Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233040. 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 EMS/TENS Massager Device?

EMS/TENS Massager Device is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K233040.

When did EMS/TENS Massager Device receive FDA 510(k) clearance?

EMS/TENS Massager Device received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233040.

Who is the listed applicant for EMS/TENS Massager Device?

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

What is the FDA product code for EMS/TENS Massager Device?

The FDA product code for EMS/TENS Massager Device 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 Imdk Medical Technology Co., Ltd. como candidato(a)

K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)K253133Wrist Blood Pressure Monitor (BPM-W1VL)K243118Arm Blood Pressure Monitor (model: BPM-A7VL)K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)K173123Pulse Oximeter K180419Ultrasonic Doppler (Model YM-2T8)

Ver todos os 7 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.