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Panels › Physical Medicine › Product code IPF · Class 2

Stimulator, Muscle, Powered

Regulation 890.5850

3510(k)s in 12 months (548 all time)
0recalls in 12 months (7 all time)
3recalls that name a 510(k)
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Top companies in IPF

Company510(k)sRecalls
Rich-Mar Corp.170
Bloomex International, Inc.140
Chattanooga Group140
Mettler Electronics Corp.130
Maximum Performance Technologies, Mpts, Inc.110
Firstkind Limited100
Empi80
Rs Medical80
Bio-Medical Research Corp.70
Biomedical Life Systems, Inc.70
Decided510(k)Device and applicantCode
Jun 8, 2026K253542Apollo Quattro (APQ-10M)
Weero Co., Ltd., KR
IPF
Jun 2, 2026K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)
Mohammadali Nezakati
IPF
May 27, 2026K260142StimelMD (SSMD) system
Motion Informatics ltd., IL
IPF
Sep 12, 2025K251083Compact II
Enraf-Nonius, B.V., NL
IPF
Jun 4, 2025K241433EVE Synergy (EVE-20M)
Weero Co., Ltd., KR
IPF
Feb 5, 2025K241488TrainFES Advance
Trainfes, CL
IPF
Dec 19, 2024K240348Quantum Mitohormesis (QMT) (M2101)
Quantumtx Pte. , Ltd., SG
IPF
Oct 10, 2024K240992eMVFit (MVF-10M)
Weero Co., Ltd., KR
IPF
Aug 17, 2024K240234BTL-899MS
BTL Industries, Inc.
IPF
Aug 2, 2024K233098MYOTouch Muscle Stimulator
Sunmed, LLC
IPF
May 16, 2024K232786Stimulation System (PA series, PR series, S series and Q series)
Edan Instruments, Inc., CN
IPF
Mar 21, 2024K233926accufit
Mettler Electronics Corporation
IPF
Jan 26, 2024K233485M-Wave
Zynex Medical, Inc.
IPF
Dec 26, 2023K232937BTL-899M
BTL Industries, Inc.
IPF
Nov 24, 2023K230701Stim2Go
PAJUNK GmbH Medizintechnologie, DE
IPF
Nov 3, 2023K231440Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co. , Ltd., CN
IPF
Oct 10, 2023K223027NeuroTrigger Basic (NTB)
Neurotrigger, IL
IPF
Oct 6, 2023K223802accufit
Mettler Electronics Corporation
IPF
Sep 29, 2023K221274StarFormer, TightWave
Fotona D.O.O., SI
IPF
Sep 14, 2023K230167BACK 4
Swims America Corp
IPF
Sep 1, 2023K232334DEKA SIMON
El.En S.P.A., IT
IPF
Jan 17, 2023K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
Hilltek, LLC
IPF
Oct 21, 2022K222201Biological Feedback and Stimulation System
Medlander Medical Technology, Inc., CN
IPF
Oct 21, 2022K221958Flex-MI
Emsi, Inc.
IPF
Oct 14, 2022K220994Shoulder PacemakerTM
Ncs Lab Srl
IPF
Jun 17, 2022K213197MyOnyx System
Thought Technology , Ltd., CA
IPF
May 12, 2022K220738Motive Knee Wrap
Cymedica Orthopedics, Inc.
IPF
Mar 4, 2022K220327geko W-3
Firstkind Limited, GB
IPF
Feb 25, 2022K213043Levator Elite (Model LE9011)
Shenzhen Dongdixin Technology Co., Ltd., CN
IPF
Dec 14, 2021K212832TimeWaver Frequency
Timewaver Production GmbH, DE
IPF
Nov 29, 2021K212762geko W-2
Firstkind Limited, GB
IPF
Oct 19, 2021K192746MyoWorx TM20
Myoworx, Inc., CA
IPF
Oct 1, 2021K210002STELLA BIO
Egzotech Sp. Z O. O., PL
IPF
Aug 24, 2021K210674Shoulder Pacemaker
Ncs Lab Srl, IT
IPF
Jul 30, 2021K210938PowerDot PD-01MT2 Muscle Stimulator
Smartmissimo Technologies Pte, Ltd., SG
IPF
Jul 8, 2021K211094Nerve and Muscle Stimulator
Shenzhen Xft Medical Limited, CN
IPF
Jun 3, 2021K210604Intellihab System
Cymedica Orthopedics, Inc.
IPF
May 13, 2021K210979Prelivia
Rehabtronics, Inc., CA
IPF
May 11, 2021K210572Neurodyn V2.0, Neurodyn Aussie V2.0
Ibramed Equipamentos Medicos, BR
IPF
May 6, 2021K202031Talent-Pro Electromagnetic Stimulator
Remed Co., Ltd., KR
IPF
May 3, 2021K203710Storz Medical MAGNETOLITH Muscle Stimulator
Storz Medical AG, CH
IPF
Mar 5, 2021K201285InMode Evolve System with the Tone Applicator
InMode , Ltd., IL
IPF
Feb 23, 2021K210269PowerDot PD-01MT2 Muscle Stimulator
Smartmissimo Technologies Pte, Ltd., SG
IPF
Feb 19, 2021K203488emField
Zimmer Medizinsysteme GmbH, DE
IPF
Dec 8, 2020K202648Biofeedback Nerve and Muscle Stimulator
Shenzhen Konmed Technology Co., Ltd., CN
IPF
Nov 25, 2020K202079Physiq
El.En Electronic Engineering Spa, IT
IPF
Nov 16, 2020K202490Avid CT2
Vision Quest Industries Inc./Dba VQ Orthocare
IPF
Oct 29, 2020K200088g.Estim FES
G.Tec Medical Engineering GmbH, AT
IPF
Sep 21, 2020K201290Medline DeNovo 4Pro Electrical Stimulation Device
Medline Industries, Inc.
IPF
Aug 4, 2020K201958ETD Family of Electrotherapy Devices
Therasigma, LLC
IPF

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