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Panels › Physical Medicine › Product code NGX · Class 2

Stimulator, Muscle, Powered, For Muscle Conditioning

Regulation 890.5850

6510(k)s in 12 months (163 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
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Top companies in NGX

Company510(k)sRecalls
Bio-Medical Research Corp.150
Zimmer Medizinsysteme GmbH60
Actegy , Ltd.50
Changsha Anxiang Medical Technology Co., Ltd.50
Sport-Elec50
Bemer Int AG31
BTL Industries, Inc.40
Djo, LLC40
Guangzhou Xinbo Electronic Co., Ltd.40
Johari Digital Healthcare , Ltd.40
Decided510(k)Device and applicantCode
Dec 13, 2021K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
Shenzhen Osto Technology Company Limited, CN
NGX
Nov 1, 2021K212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Guangzhou Xinbo Electronic Co., Ltd., CN
NGX
Oct 21, 2021K200545Legend Pro DMA
Pollogen, Ltd., IL
NGX
Aug 25, 2021K202148E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
Fit-Pro , Ltd., HU
NGX
Jul 15, 2021K202638Pain Therapy Device
Guangzhou Xinbo Electronic Co., Ltd., CN
NGX
Apr 6, 2021K201257MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Arrive Systems, Inc.
NGX
Mar 11, 2021K201975miha bodytec II
Miha Bodytec GmbH, DE
NGX
Feb 10, 2021K203513SLENDERTONE Evolve Abs, Type 735
Bio-Medical Research, Ltd., IE
NGX
Feb 4, 2021K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
Bemer Int AG, LI
NGX
Jan 15, 2021K202653Gymform Total ABS
Well Brain International , Ltd., CN
NGX
Jan 6, 2021K200382BTL-703-2
Btl
NGX
Dec 31, 2020K201239NuEra Tight Family, EMS Model
Bios S.R.L., IT
NGX
Dec 11, 2020K201354TENS & PMS
Hong Qiangxing (Shenzhen) Electronics Limited, CN
NGX
Nov 27, 2020K201653Compex Sport Elite 3.0
Djo, LLC
NGX
Oct 8, 2020K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Guangzhou Longest Science & Technology Co., Ltd., CN
NGX
Sep 17, 2020K182020Portable Electro-Stimulation Therapy Device
Guangzhou Longest Science & Technology Co., Ltd., CN
NGX
Aug 28, 2020K191938FitRelief TENS&EMS Wireless Device
Heat IN A Click, LLC
NGX
May 28, 2020K201131firefly T-2
Firstkind Limited, GB
NGX
May 4, 2020K192887Revitive Medic Plus, Revitive Advanced 2
Actegy , Ltd., GB
NGX
Mar 29, 2020K192039Torc Body
Johari Digital Healthcare Limited, IN
NGX
Feb 3, 2020K190966Katalyst Training System
Katalyst, Inc.
NGX
Jan 22, 2020K192161FastFit EMS System
Fast Fit, LLC
NGX
Nov 15, 2019K192940CoolTone
Zimmer Medizinsysteme GmbH, DE
NGX
Nov 8, 2019K192264HIVOX Spopad EMS SP-911, SP-921
Hivox Biotek, Inc., TW
NGX
Oct 11, 2019K191181NXPRO Neuromuscular Electrical Stimulation Device
Neux Technologies, Inc.
NGX
Sep 18, 2019K183103EMS Belt (Model MC0485)
Dongguan Yingfeng Metal & Plastic Products Co., Ltd., CN
NGX
Jul 18, 2019K182794BionicGym Powered Muscle Stimulator
Medical Currents, Ltd., IE
NGX
Jul 5, 2019K190924Revitive Medic Plus, Revitive Advanced 2
Actegy , Ltd., GB
NGX
Jul 5, 2019K190456BTL 799-2L
BTL Industries, Inc.
NGX
Jun 21, 2019K182963emFieldPro
Zimmer Medizinsysteme GmbH, DE
NGX
Jun 7, 2019K182519Miha Bodytec II
Miha Bodytec GmbH, DE
NGX
May 14, 2019K181419FLIX-EMS
Casgarum Investment, S.L., ES
NGX
Apr 5, 2019K190038Xbody Newave USA
Xbody Hungary Kft., HU
NGX
Feb 26, 2019K183454Tyece OTC EMS System
Tyece , Ltd., HK
NGX
Feb 26, 2019K182440Body System
A-1 Engineering
NGX
Feb 12, 2019K181955WiEMSpro
Medical Cables S.L., ES
NGX
Oct 25, 2018K180688SLENDERTONE CoreFit Abs 8, Type 734
Bio-Medical Research, Ltd., IE
NGX
Oct 23, 2018K182106BTL 799-2T
BTL Industries, Inc.
NGX
Oct 17, 2018K181728Muscle Trainer
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NGX
Sep 20, 2018K181199Katalyst Mark 1 Muscle Stimulation System Model 2
Katalyst, Inc.
NGX
Jun 14, 2018K180813BTL 799-2
BTL Industries, Inc.
NGX
May 9, 2018K180279Silk'n MODEL H5003 device
Home Skinovations , Ltd., IL
NGX
Dec 4, 2017K172876PowerDot PD-01M
Smartmissimo Technologies Pte, Ltd., SG
NGX
Nov 20, 2017K172241Tyece OTC EMS System, Model EM35
Tyece , Ltd., HK
NGX
Sep 6, 2017K171035Katalyst Mark 1 Muscle Stimulation System
Katalyst, Inc.
NGX
Aug 3, 2017K162744Everyway OTC EMS, Model EV-805
Everyway Medical Instrument Co., Ltd., TW
NGX
Jul 10, 2017K171092XiniWave II Model ECS322P
International Trade Group, Inc.
NGX
Jun 20, 2017K170918Compex Sport Elite
Djo, LLC
NGX
Jun 19, 2017K170903Compex Wireless USA
Djo, LLC
NGX
Apr 6, 2017K160323FlowKeepers
Dk Electronics, LLC
NGX

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