Stimulator, Muscle, Powered

FDA product code IPF · 541 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5850
Review panel: PM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-09-27 – 2026-06-08

IPF 2026-06-08

Apollo Quattro (APQ-10M)

Applicant Weero Co., Ltd.

K number K253542

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IPF 2026-06-02

High Tone Power therapy (HiToP) (Model: HiToP PNP)

Applicant Mohammadali Nezakati

K number K252816

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IPF 2026-05-27

StimelMD (SSMD) system

Applicant Motion Informatics ltd.

K number K260142

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IPF 2025-09-12

Compact II

Applicant Enraf-Nonius, B.V.

K number K251083

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IPF 2025-06-04

EVE Synergy (EVE-20M)

Applicant Weero Co., Ltd.

K number K241433

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IPF 2025-02-05

TrainFES Advance

Applicant Trainfes

K number K241488

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IPF 2024-12-19

Quantum Mitohormesis (QMT) (M2101)

Applicant Quantumtx Pte. , Ltd.

K number K240348

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IPF 2024-10-10

eMVFit (MVF-10M)

Applicant Weero Co., Ltd.

K number K240992

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IPF 2024-08-17

BTL-899MS

Applicant BTL Industries, Inc.

K number K240234

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IPF 2024-08-02

MYOTouch Muscle Stimulator

Applicant Sunmed, LLC

K number K233098

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IPF 2024-05-16

Stimulation System (PA series, PR series, S series and Q series)

Applicant Edan Instruments, Inc.

K number K232786

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IPF 2024-03-21

accufit

Applicant Mettler Electronics Corporation

K number K233926

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IPF 2024-01-26

M-Wave

Applicant Zynex Medical, Inc.

K number K233485

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IPF 2023-12-26

BTL-899M

Applicant BTL Industries, Inc.

K number K232937

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IPF 2023-11-24

Stim2Go

Applicant PAJUNK GmbH Medizintechnologie

K number K230701

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IPF 2023-11-03

Combo Electrotherapy Device

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K number K231440

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IPF 2023-10-10

NeuroTrigger Basic (NTB)

Applicant Neurotrigger

K number K223027

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IPF 2023-10-06

accufit

Applicant Mettler Electronics Corporation

K number K223802

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IPF 2023-09-29

StarFormer, TightWave

Applicant Fotona D.O.O.

K number K221274

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IPF 2023-09-14

BACK 4

Applicant Swims America Corp

K number K230167

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IPF 2023-09-01

DEKA SIMON

Applicant El.En S.P.A.

K number K232334

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IPF 2023-01-17

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

Applicant Hilltek, LLC

K number K213655

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IPF 2022-10-21

Biological Feedback and Stimulation System

Applicant Medlander Medical Technology, Inc.

K number K222201

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IPF 2022-10-21

Flex-MI

Applicant Emsi, Inc.

K number K221958

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IPF 2022-10-14

Shoulder PacemakerTM

Applicant Ncs Lab Srl

K number K220994

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IPF 2022-06-17

MyOnyx System

Applicant Thought Technology , Ltd.

K number K213197

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IPF 2022-05-12

Motive Knee Wrap

Applicant Cymedica Orthopedics, Inc.

K number K220738

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IPF 2022-03-04

geko W-3

Applicant Firstkind Limited

K number K220327

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IPF 2022-02-25

Levator Elite (Model LE9011)

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K213043

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IPF 2021-12-14

TimeWaver Frequency

Applicant Timewaver Production GmbH

K number K212832

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IPF 2021-11-29

geko W-2

Applicant Firstkind Limited

K number K212762

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IPF 2021-10-19

MyoWorx TM20

Applicant Myoworx, Inc.

K number K192746

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IPF 2021-10-01

STELLA BIO

Applicant Egzotech Sp. Z O. O.

K number K210002

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IPF 2021-08-24

Shoulder Pacemaker

Applicant Ncs Lab Srl

K number K210674

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IPF 2021-07-30

PowerDot PD-01MT2 Muscle Stimulator

Applicant Smartmissimo Technologies Pte, Ltd.

K number K210938

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IPF 2021-07-08

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K number K211094

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IPF 2021-06-03

Intellihab System

Applicant Cymedica Orthopedics, Inc.

K number K210604

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IPF 2021-05-13

Prelivia

Applicant Rehabtronics, Inc.

K number K210979

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IPF 2021-05-11

Neurodyn V2.0, Neurodyn Aussie V2.0

Applicant Ibramed Equipamentos Medicos

K number K210572

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IPF 2021-05-06

Talent-Pro Electromagnetic Stimulator

Applicant Remed Co., Ltd.

K number K202031

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IPF 2021-05-03

Storz Medical MAGNETOLITH Muscle Stimulator

Applicant Storz Medical AG

K number K203710

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IPF 2021-03-05

InMode Evolve System with the Tone Applicator

Applicant InMode , Ltd.

K number K201285

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IPF 2021-02-23

PowerDot PD-01MT2 Muscle Stimulator

Applicant Smartmissimo Technologies Pte, Ltd.

K number K210269

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IPF 2021-02-19

emField

Applicant Zimmer Medizinsysteme GmbH

K number K203488

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IPF 2020-12-08

Biofeedback Nerve and Muscle Stimulator

Applicant Shenzhen Konmed Technology Co., Ltd.

K number K202648

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IPF 2020-11-25

Physiq

Applicant El.En Electronic Engineering Spa

K number K202079

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IPF 2020-11-16

Avid CT2

Applicant Vision Quest Industries Inc./Dba VQ Orthocare

K number K202490

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IPF 2020-10-29

g.Estim FES

Applicant G.Tec Medical Engineering GmbH

K number K200088

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IPF 2020-09-21

Medline DeNovo 4Pro Electrical Stimulation Device

Applicant Medline Industries, Inc.

K number K201290

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IPF 2020-08-04

ETD Family of Electrotherapy Devices

Applicant Therasigma, LLC

K number K201958

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IPF 2020-04-11

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K number K193275

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IPF 2020-01-18

geko™ W-2

Applicant Firstkind Limited

K number K193045

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IPF 2020-01-11

TENS and EMS Stimulator, TENS Stimulator

Applicant Astek Technology , Ltd.

K number K183074

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IPF 2019-12-23

RelieforMe TENS/EMS Device Model UPK-GE01

Applicant Umeheal , Ltd.

K number K192733

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IPF 2019-12-17

InMode System with Tone Applicator

Applicant InMode , Ltd.

K number K192249

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IPF 2019-09-18

geko T-2 and geko T-3 Neuromuscular Stimulators

Applicant Firstkind Limited

K number K191113

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IPF 2019-07-09

Shear Stress Therapeutics SST 3000

Applicant Shear Stress Therapeutics, LLC

K number K182163

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IPF 2018-11-09

PowerDot PD-01MT

Applicant Smartmissimo Technologies Pte, Ltd.

K number K181759

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IPF 2018-09-07

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K number K181688

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IPF 2018-05-23

geko T-3 Neuromuscular Stimulator

Applicant Firstkind Limited

K number K181059

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IPF 2018-03-06

Digitimer DS7AP Constant Current Stimulator

Applicant Digitimer , Ltd.

K number K172381

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IPF 2018-02-11

geko T-2 and geko Plus R-2

Applicant Firstkind, Ltd.

K number K180082

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IPF 2017-10-02

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K171978

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IPF 2017-08-09

StimSox(TM) System

Applicant Stimmed, LLC

K number K171071

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IPF 2017-05-31

EMS100 Tri-Wave Combination Stimulator

Applicant Elite Medical Supply of New York, LLC

K number K171387

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IPF 2017-04-10

geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators

Applicant Firstkind Limited

K number K163125

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IPF 2017-02-14

FA100 SCCD (Sequential Continuous Contraction Device)

Applicant Flowaid Medical Technologies, Corp

K number K162987

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IPF 2016-12-16

Xcite Clinical Station

Applicant Restorative Therapies, Inc.

K number K160614

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IPF 2016-12-01

CyMedica e-vive™ System; CY-1000

Applicant Cymedica Orthopedics, Inc.

K number K163067

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IPF 2016-10-21

HPM-6000

Applicant BTL Industries, Inc.

K number K160992

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IPF 2016-04-15

StimSox(TM) System

Applicant Stimmed, LLC

K number K151922

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IPF 2016-04-14

Chattanooga Revolution Wireless

Applicant Djo, LLC

K number K153696

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IPF 2016-04-08

geko(TM) Plus R-2 Neuromuscular Stimulator

Applicant Firstkind Limited

K number K160299

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IPF 2016-02-17

VitalStim(R) Plus Electrotherapy System

Applicant Djo, LLC

K number K153224

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IPF 2013-12-20

ELECTROTHERAPY DEVICE (COMBO UNIT)

Applicant Guangzhou Finecure Medical Equipment Co.,Ltd

K number K130691

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IPF 2013-12-20

TONE-A-MATIC

Applicant Tone-A-Matic International, Inc.

K number K130052

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IPF 2013-11-26

NEURODYN MULTIWAVE, AUSSIE SPORT

Applicant Ibramed Equipamentos Medicos

K number K131629

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IPF 2013-10-31

AMPCARE ESP THERAPY SYSTEM

Applicant Ampcare, LLC

K number K131222

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IPF 2013-09-12

MULTISTIM

Applicant Metron Medical Australia, Pty, Ltd.

K number K132137

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IPF 2013-07-11

STIMEL-03

Applicant Stimel, Ltd.

K number K130424

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IPF 2013-06-28

REVITIVE IX

Applicant Actegy , Ltd.

K number K123354

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IPF 2013-05-06

EMPI PHOENIX

Applicant Djo, LLC

K number K124016

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IPF 2013-03-29

MUSCLE STIMULATION SYSTEM

Applicant Niveus Medical, Inc.

K number K123642

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IPF 2013-02-07

GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

Applicant Selectivemed Components, Inc.

K number K120922

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IPF 2012-12-21

FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR

Applicant Famidoc Technology Co., Ltd.

K number K113010

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IPF 2012-06-26

SYS*STIM 240

Applicant Mettler Electronics Corp.

K number K113017

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IPF 2012-04-30

POWERED MUSCLE STIMULATOR

Applicant Valmed, SA

K number K112148

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IPF 2012-01-19

RS-4I MUSCLE STIMULATOR

Applicant Rs Medical

K number K112348

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IPF 2011-09-20

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM

Applicant Zynex Medical, Inc.

K number K111279

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IPF 2011-06-01

H-WAVE

Applicant Electronic Waveform Laboratory, Inc.

K number K103738

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IPF 2011-04-21

BODYFLOW P2CH

Applicant Physiomed Elektromedizin AG

K number K100862

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IPF 2011-02-10

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT

Applicant Eswallow USA

K number K092202

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IPF 2010-11-23

GS 3000

Applicant Emsi

K number K102202

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IPF 2010-03-05

EMPI CONTINUUM

Applicant Empi

K number K093324

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IPF 2010-02-12

MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K093138

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IPF 2010-01-29

LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K100117

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IPF 2009-12-30

KNEEHAB XP CONTROLLER, MODEL 411

Applicant Bio-Medical Research, Ltd.

K number K092791

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IPF 2009-12-17

ARP RX100

Applicant Arp Manufacturing, Inc.

K number K093259

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IPF 2009-11-30

MAXEMS, MODELS 1000 AND 2000

Applicant Bio Protech, Inc.

K number K091248

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IPF 2009-11-13

T.E.A.R. TECH3

Applicant Vision Quest Industries, Inc.

K number K090532

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