Atlas FDA

IPF

548 FDA 510(k) clearances · Product code

108 daysmedian time to decision
338 days90th percentile
548clearances measured

FDA profile

Official device name
Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2011: 25 · 2012: 16 · 2013: 6 · 2014: 19 · 2015: 11 · 2020: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Apollo Quattro (APQ-10M) (K253542)Weero Co., Ltd.2026-06-08
High Tone Power therapy (HiToP) (Model: HiToP PNP) (K252816)Mohammadali Nezakati2026-06-02
StimelMD (SSMD) system (K260142)Motion Informatics ltd.2026-05-27
Compact II (K251083)Enraf-Nonius, B.V.2025-09-12
EVE Synergy (EVE-20M) (K241433)Weero Co., Ltd.2025-06-04
TrainFES Advance (K241488)Trainfes2025-02-05
Quantum Mitohormesis (QMT) (M2101) (K240348)Quantumtx Pte. , Ltd.2024-12-19
eMVFit (MVF-10M) (K240992)Weero Co., Ltd.2024-10-10
BTL-899MS (K240234)BTL Industries, Inc.2024-08-17
MYOTouch Muscle Stimulator (K233098)Sunmed, LLC2024-08-02
Stimulation System (PA series, PR series, S series and Q series) (K232786)Edan Instruments, Inc.2024-05-16
accufit (K233926)Mettler Electronics Corporation2024-03-21
M-Wave (K233485)Zynex Medical, Inc.2024-01-26
BTL-899M (K232937)BTL Industries, Inc.2023-12-26
Stim2Go (K230701)PAJUNK GmbH Medizintechnologie2023-11-24
Combo Electrotherapy Device (K231440)Shenzhen Roundwhale Technology Co. , Ltd.2023-11-03
NeuroTrigger Basic (NTB) (K223027)Neurotrigger2023-10-10
accufit (K223802)Mettler Electronics Corporation2023-10-06
StarFormer, TightWave (K221274)Fotona D.O.O.2023-09-29
BACK 4 (K230167)Swims America Corp2023-09-14
DEKA SIMON (K232334)El.En S.P.A.2023-09-01
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (K213655)Hilltek, LLC2023-01-17
Biological Feedback and Stimulation System (K222201)Medlander Medical Technology, Inc.2022-10-21
Flex-MI (K221958)Emsi, Inc.2022-10-21
Shoulder PacemakerTM (K220994)Ncs Lab Srl2022-10-14
MyOnyx System (K213197)Thought Technology , Ltd.2022-06-17
Motive Knee Wrap (K220738)Cymedica Orthopedics, Inc.2022-05-12
geko W-3 (K220327)Firstkind Limited2022-03-04
Levator Elite (Model LE9011) (K213043)Shenzhen Dongdixin Technology Co., Ltd.2022-02-25
TimeWaver Frequency (K212832)Timewaver Production GmbH2021-12-14
geko W-2 (K212762)Firstkind Limited2021-11-29
MyoWorx TM20 (K192746)Myoworx, Inc.2021-10-19
STELLA BIO (K210002)Egzotech Sp. Z O. O.2021-10-01
Shoulder Pacemaker (K210674)Ncs Lab Srl2021-08-24
PowerDot PD-01MT2 Muscle Stimulator (K210938)Smartmissimo Technologies Pte, Ltd.2021-07-30
Nerve and Muscle Stimulator (K211094)Shenzhen Xft Medical Limited2021-07-08
Intellihab System (K210604)Cymedica Orthopedics, Inc.2021-06-03
Prelivia (K210979)Rehabtronics, Inc.2021-05-13
Neurodyn V2.0, Neurodyn Aussie V2.0 (K210572)Ibramed Equipamentos Medicos2021-05-11
Talent-Pro Electromagnetic Stimulator (K202031)Remed Co., Ltd.2021-05-06
Storz Medical MAGNETOLITH Muscle Stimulator (K203710)Storz Medical AG2021-05-03
InMode Evolve System with the Tone Applicator (K201285)InMode , Ltd.2021-03-05
PowerDot PD-01MT2 Muscle Stimulator (K210269)Smartmissimo Technologies Pte, Ltd.2021-02-23
emField (K203488)Zimmer Medizinsysteme GmbH2021-02-19
Biofeedback Nerve and Muscle Stimulator (K202648)Shenzhen Konmed Technology Co., Ltd.2020-12-08
Physiq (K202079)El.En Electronic Engineering Spa2020-11-25
Avid CT2 (K202490)Vision Quest Industries Inc./Dba VQ Orthocare2020-11-16
g.Estim FES (K200088)G.Tec Medical Engineering GmbH2020-10-29
Medline DeNovo 4Pro Electrical Stimulation Device (K201290)Medline Industries, Inc.2020-09-21
ETD Family of Electrotherapy Devices (K201958)Therasigma, LLC2020-08-04
Nerve and Muscle Stimulator (K193275)Shenzhen Xft Medical Limited2020-04-11
geko™ W-2 (K193045)Firstkind Limited2020-01-18
TENS and EMS Stimulator, TENS Stimulator (K183074)Astek Technology , Ltd.2020-01-11
RelieforMe TENS/EMS Device Model UPK-GE01 (K192733)Umeheal , Ltd.2019-12-23
InMode System with Tone Applicator (K192249)InMode , Ltd.2019-12-17
geko T-2 and geko T-3 Neuromuscular Stimulators (K191113)Firstkind Limited2019-09-18
Shear Stress Therapeutics SST 3000 (K182163)Shear Stress Therapeutics, LLC2019-07-09
PowerDot PD-01MT (K181759)Smartmissimo Technologies Pte, Ltd.2018-11-09
R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (K181688)Shenzhen Roundwhale Technology Co. , Ltd.2018-09-07
geko T-3 Neuromuscular Stimulator (K181059)Firstkind Limited2018-05-23
Digitimer DS7AP Constant Current Stimulator (K172381)Digitimer , Ltd.2018-03-06
geko T-2 and geko Plus R-2 (K180082)Firstkind, Ltd.2018-02-11
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (K171978)Shenzhen Dongdixin Technology Co., Ltd.2017-10-02
StimSox(TM) System (K171071)Stimmed, LLC2017-08-09
EMS100 Tri-Wave Combination Stimulator (K171387)Elite Medical Supply of New York, LLC2017-05-31
geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators (K163125)Firstkind Limited2017-04-10
FA100 SCCD (Sequential Continuous Contraction Device) (K162987)Flowaid Medical Technologies, Corp2017-02-14
Xcite Clinical Station (K160614)Restorative Therapies, Inc.2016-12-16
CyMedica e-vive™ System; CY-1000 (K163067)Cymedica Orthopedics, Inc.2016-12-01
HPM-6000 (K160992)BTL Industries, Inc.2016-10-21
StimSox(TM) System (K151922)Stimmed, LLC2016-04-15
Chattanooga Revolution Wireless (K153696)Djo, LLC2016-04-14
geko(TM) Plus R-2 Neuromuscular Stimulator (K160299)Firstkind Limited2016-04-08
VitalStim(R) Plus Electrotherapy System (K153224)Djo, LLC2016-02-17
geko T-2 Neuromuscular Stimulator (K152677)Firstkind Limited2015-10-23
Muscle Stimulation System 110 (K150742)Niveus Medical, Inc.2015-07-23
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator (K150413)Cymedica Orthopedics, Inc.2015-04-02
FLEX-MT + (K140467)Emsi2014-10-07
GEKO (K133638)Firstkind Limited2014-08-21
NEURODYN COMPACT, NEURODYN II (K131917)Ibramed Equipamentos Medicos2014-04-29
VECTRA NEO CLINICAL THERAPY SYSTEM (K132284)Djo, LLC2014-04-10
TONE-A-MATIC (K130052)Tone-A-Matic International, Inc.2013-12-20
ELECTROTHERAPY DEVICE (COMBO UNIT) (K130691)Guangzhou Finecure Medical Equipment Co.,Ltd2013-12-20
NEURODYN MULTIWAVE, AUSSIE SPORT (K131629)Ibramed Equipamentos Medicos2013-11-26
AMPCARE ESP THERAPY SYSTEM (K131222)Ampcare, LLC2013-10-31
MULTISTIM (K132137)Metron Medical Australia, Pty, Ltd.2013-09-12
STIMEL-03 (K130424)Stimel, Ltd.2013-07-11
REVITIVE IX (K123354)Actegy , Ltd.2013-06-28
EMPI PHOENIX (K124016)Djo, LLC2013-05-06
MUSCLE STIMULATION SYSTEM (K123642)Niveus Medical, Inc.2013-03-29
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT (K120922)Selectivemed Components, Inc.2013-02-07
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR (K113010)Famidoc Technology Co., Ltd.2012-12-21
SYS*STIM 240 (K113017)Mettler Electronics Corp.2012-06-26
POWERED MUSCLE STIMULATOR (K112148)Valmed, SA2012-04-30
RS-4I MUSCLE STIMULATOR (K112348)Rs Medical2012-01-19
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (K111279)Zynex Medical, Inc.2011-09-20
H-WAVE (K103738)Electronic Waveform Laboratory, Inc.2011-06-01
BODYFLOW P2CH (K100862)Physiomed Elektromedizin AG2011-04-21
ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT (K092202)Eswallow USA2011-02-10
GS 3000 (K102202)Emsi2010-11-23
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