FDA 510(k)

OTC Combo TENS/EMS System

N.º K: K172809 · 2017-10-18

Fecha de decisión2017-10-18

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

OTC Combo TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172809. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OTC Combo TENS/EMS System?

OTC Combo TENS/EMS System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K172809.

When did OTC Combo TENS/EMS System receive FDA 510(k) clearance?

OTC Combo TENS/EMS System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172809.

Who is the listed applicant for OTC Combo TENS/EMS System?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC Combo TENS/EMS System?

The FDA product code for OTC Combo TENS/EMS System is NUH.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Well-Life Healthcare Limited como solicitante

K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K213091Well-Life TENS/EMS/Heating Stimulator K200942Well-Life Garment Electrodes (GM Series)K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

Ver todos los 8 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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.