510(k) Report

Devices descending from K984142

34 later devices reach Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp.200719—
+1K032793US-100 Portable Ultrasound Therapy UnitIto Co., Ltd.20035—
+1K013192Sonicator Plus 930, Model ME 930Mettler Electronics Corp.200111—
+2K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10Shenzhen Dongdixin Technology Co., Ltd.20172—
+2K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical, Ltd.20170—
+2K131309Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIbramed Equipamentos Medicos20144—
+2K130888Sonopulse/ Sonopulse IiiIbramed- Industria Brazileria DE Equipamentos Medi20145—
+2K112520US-101L, US-103SIto Co., Ltd.20114—
+2K111482Sonicator Plus 920Mettler Electronics Corp.20111—
+2K093138MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Shenzhen Dongdixin Technology Co., Ltd.2010151
+2K092627CT2011 Sonicstimu Pain Relief DeviceShenzhen Dongdixin Technology Co., Ltd.20100—
+2K052340DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd.20052—
+3K231440Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd.20230—
+3K213197MyOnyx SystemThought Technology, Ltd.20220—
+3K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto20214—
+3K182108Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.20190—
+3K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc.20163—
+3K113010FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd.20128—
+3K120054Ultima NeoPain Management Technologies20122—
+3K063728TNN-DU810 Non-Invasive Subdermal Therapy SystemAlfa Tech Medical Systems, Ltd.20070—
+4K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+4K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.20241—
+4K230472Sonopuls 190Enraf-Nonius, B.V.20233—
+4K183074TENS and EMS Stimulator, TENS StimulatorAstek Technology, Ltd.20200—
+4K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd.20186—
+5K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+5K251334New Doublo 2.0Hironic Co., Ltd.20250—
+5K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—
+5K210021Axon TherapyNeuralace Medical, Inc.20215—
+6K233364Axon TherapyNeuralace Medical, Inc.20241—
+6K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S20233—
+7K250309BTL-199BTL Industries, Inc.20250—
+7K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited20250—
+7K241785StarFormer (M008-3T)Fotona D.O.O.20250—