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 2009-07-24

KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

Applicant Bio-Medical Research, Ltd.

K number K083105

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IPF 2009-06-01

COMPEX REHAB

Applicant Chattanooga Group

K number K090632

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IPF 2009-04-02

STIWELL MED4

Applicant Otto Bock, Austria GmbH

K number K080950

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IPF 2008-07-11

SRT II MUSCLE STIMULATOR

Applicant Therapeutic Innovations, Inc.

K number K071677

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IPF 2008-07-03

COMBI 8 MAX

Applicant Cec Electronica S.R.L.

K number K070888

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IPF 2008-04-17

BIOMOVE 5000 SYSTEM

Applicant Curatronic, Ltd.

K number K080787

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IPF 2008-03-24

MODELS TENS 7000, EMS 7500 AND TWIN STIM

Applicant Koalaty Products, Inc.

K number K080661

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IPF 2008-03-18

MUSCLE PAIN DEVICE (MPD)

Applicant Stevens Proof of Concept, Inc.

K number K073361

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IPF 2008-01-30

VEINOPLUS NEUROMUSCULAR STIMULATOR

Applicant Ad Rem Technology Sarl

K number K072252

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IPF 2007-12-13

FD EMS, MODEL # D-FJ30E

Applicant Fuji Dynamics Limited

K number K063642

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IPF 2007-12-06

SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202

Applicant San Shih Electrical Enterprise Co., Ltd.

K number K071093

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IPF 2007-11-27

MODELS EMS 5.0, EMS 5.1

Applicant Koalaty Products, Inc.

K number K072795

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IPF 2007-09-21

GLOBUS GENESY 1100 STIMULATOR

Applicant Domino S.R.L.

K number K071431

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IPF 2007-08-17

EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

Applicant Everlife Medical Equipment Co., Ltd.

K number K071320

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IPF 2007-06-11

VITALSTIM EXPERIA

Applicant Chattanooga Group

K number K070425

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IPF 2007-04-17

KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138

Applicant Kingly Star Intl. Technology Co., Ltd.

K number K062453

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IPF 2007-01-26

VECTRA GENISYS VMS FR

Applicant Encore Medical L.P.

K number K062354

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IPF 2006-01-05

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

Applicant Durtech System Corp.

K number K053285

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IPF 2005-12-29

MYOTRAC INFINITI

Applicant Thought Technology , Ltd.

K number K053266

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IPF 2005-12-12

EASYSTIM NMS-28

Applicant Easy Med Instrument Co., Ltd.

K number K050921

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IPF 2005-08-11

AXIOM NVP8500

Applicant Axiom Worldwide, Inc.

K number K051135

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IPF 2005-07-28

AXIOM EPS8000

Applicant Axiom Worldwide, Inc.

K number K050687

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IPF 2005-06-17

IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A

Applicant Theratech, Inc.

K number K050847

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IPF 2005-05-23

FT2000 SEQUENCER FOR MUSCLE STIMULATOR

Applicant Midwest Development

K number K050595

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IPF 2005-04-13

REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S

Applicant Compex Technologies, Inc.

K number K050046

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IPF 2005-03-04

NEUROTECH KNEEHAB

Applicant Bio-Medical Research, Ltd.

K number K024258

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IPF 2005-02-09

DIAMOND MEDISTIM

Applicant Diamond Systems USA, Inc.

K number K041390

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IPF 2005-01-27

BIOMOVE 3000

Applicant Curatronic, Ltd.

K number K042650

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IPF 2005-01-21

INFINITY PLUS ELECTROTHERAPY SYSTEM

Applicant Empi

K number K041920

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IPF 2004-12-01

SMARTWAVE MS 2000

Applicant Newwave Medical, LLC

K number K041063

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IPF 2004-11-18

PMD-2000 INTERFERENTIAL STIMULATOR

Applicant Phoenix Medical Devices, LLC

K number K042881

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IPF 2004-11-18

SDS-4I

Applicant Skylark Device & Systems Co., Ltd.

K number K034005

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IPF 2004-10-01

MENTAMOVE

Applicant Cole & Associates

K number K040849

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IPF 2004-08-09

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80

Applicant Danmeter A/S

K number K032954

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IPF 2004-06-30

BMLS03-3

Applicant Biomedical Life Systems, Inc.

K number K033174

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IPF 2004-06-08

CONTROL SOLUTIONS, INC., MODEL CS3102 HVG

Applicant Control Solutions, Inc.

K number K041146

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IPF 2004-04-12

TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR

Applicant Tai Sheng Electrical Machinery Co., Ltd.

K number K031310

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IPF 2004-03-23

HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7

Applicant Biomedical Life Systems, Inc.

K number K040306

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IPF 2003-12-15

AUTOMOVE, MODEL AM800

Applicant Danmeter A/S

K number K032955

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IPF 2003-12-10

ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607

Applicant Everyway Medical Instruments Co.,Ltd

K number K033544

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IPF 2003-11-20

BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

Applicant Besmed Health Business Corp

K number K031375

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IPF 2003-11-12

ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660

Applicant Multinational

K number K031820

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IPF 2003-10-29

NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P

Applicant Everyway Medical Instruments Co.,Ltd

K number K033140

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IPF 2003-10-29

HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES

Applicant Home Care Technology Co., Ltd.

K number K023000

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IPF 2003-10-22

AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

Applicant Rich-Mar Corp.

K number K032941

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IPF 2003-10-15

RHYTHM TOUCH Q 2-WAY

Applicant Shockim Enterprises, Ltd.

K number K032178

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IPF 2003-10-10

MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300

Applicant Healthonics, Inc.

K number K030998

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IPF 2003-09-12

RS-4I MUSCLE STIMULATOR FAMILY

Applicant Rs Medical

K number K032652

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IPF 2003-08-19

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1

Applicant Biomedical Life Systems, Inc.

K number K031427

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IPF 2003-07-17

CEFAR REHAB 2 AND REHAB 2 PRO

Applicant Cefar Medical AB

K number K030403

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IPF 2003-07-17

ELECTROMEDICARIN 900

Applicant Electromedicarin, S.A.

K number K020478

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IPF 2003-06-30

INTERFERENTIAL STIMULATOR, MODEL NETWAVE

Applicant Ryan Telemedicine

K number K031884

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IPF 2003-06-26

PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM

Applicant Prizm Medical, Inc.

K number K024181

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IPF 2003-06-19

CARE ETS

Applicant Care Rehab and Orthopaedic

K number K023036

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IPF 2003-05-30

SYS*STIM 208 AND 208A

Applicant Mettler Electronics Corp.

K number K031017

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IPF 2003-05-20

T.E.A.R. TECH3 MODEL #44TT03

Applicant Vision Quest Industries, Inc.

K number K030507

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IPF 2003-05-20

HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312

Applicant Home Care Technology Co., Ltd.

K number K022998

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IPF 2003-05-05

ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800

Applicant Western Clinical Technology Systems, Inc.

K number K023230

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IPF 2003-04-08

HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L

Applicant Home Care Technology Co., Ltd.

K number K023001

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IPF 2003-03-28

VECTORSURGE 5 MODEL 470

Applicant Metron Medical Australia, Pty, Ltd.

K number K030648

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IPF 2003-03-03

TENSCARE ULTIMA NMS/EMS

Applicant Tenscare, Ltd.

K number K023997

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IPF 2003-02-26

INTERFERENTIAL STIMULATOR, MODEL RTM1000

Applicant Ryan Telemedicine

K number K030254

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IPF 2003-02-13

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5

Applicant Biomedical Life Systems, Inc.

K number K021588

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IPF 2003-01-13

MEDS-3 NEUROMUSCULAR STIMULATOR

Applicant Medical Equipment Device Specialists

K number K023446

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IPF 2003-01-13

MEDS-4 NEUROMUSCULAR STIMULATOR

Applicant Medical Equipment Device Specialists

K number K023439

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IPF 2002-12-20

PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000

Applicant Johari Digital Healthcare , Ltd.

K number K024036

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IPF 2002-12-06

VITAL STIM

Applicant Chattanooga Group

K number K023347

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IPF 2002-12-02

ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M

Applicant Rolor Electronics Corp.

K number K020130

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IPF 2002-10-31

DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS

Applicant Everyway Medical Instruments Co.,Ltd

K number K020750

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IPF 2002-10-11

EMS 400

Applicant Body Clock Health Care, Ltd.

K number K022493

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IPF 2002-09-11

NESS SYSTEM

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K022776

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IPF 2002-09-09

P4 PHYSIO

Applicant Valmed Corp.

K number K022175

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IPF 2002-09-05

CLASSIC NMS

Applicant Care Rehab, Inc.

K number K021905

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IPF 2002-08-06

HMS-DHR-3 NEUROMUSCULAR STIMULATOR

Applicant Home Medical Services

K number K021472

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IPF 2002-07-11

NEUROTECH MEDISTIM PLUS, TYPE 291

Applicant Bio-Medical Research, Ltd.

K number K014019

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IPF 2002-07-03

POWERED MUSCLE STIMULATOR

Applicant Theratech, Inc.

K number K013768

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IPF 2002-06-28

APEX MEDICAL DIGITAL EMS TS1311, TS1312

Applicant Apex Medical Corp.

K number K021754

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IPF 2002-06-18

300 PV COMPLETE ELECTROTHERAPY SYSTEM

Applicant Empi

K number K021100

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IPF 2002-06-13

RS2MI MUSCLE STIMULATOR FAMILY

Applicant Rs Medical

K number K021763

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IPF 2002-05-28

SELECT STIM

Applicant Care Rehab and Orthopaedic

K number K020637

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IPF 2002-05-23

FINESUN EMS STIMULATOR

Applicant Finesun Worldwide Intl. Co., Ltd.

K number K020684

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IPF 2002-04-30

DIGI-PRO TENS, MODEL WL-2204 AND WL-2205

Applicant Well-Life Healthcare, Inc.

K number K020314

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IPF 2002-03-28

SURETONE

Applicant Suretone International

K number K011588

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IPF 2002-01-18

BIO SPA INTELLIGENT

Applicant Starbene

K number K992099

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IPF 2002-01-18

MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

Applicant Rich-Mar Corp.

K number K013771

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IPF 2002-01-18

MODIFICATION TO: WINNER ST-2 STIMULATOR

Applicant Rich-Mar Corp.

K number K013770

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IPF 2001-11-20

MEDSTAR 150

Applicant Mednet Services, Inc.

K number K013081

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IPF 2001-11-08

NEUROMOVE NM900

Applicant Dan Med, Inc.

K number K012885

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IPF 2001-10-26

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES

Applicant Sun-Rain System Corp.

K number K011913

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IPF 2001-10-24

EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188

Applicant 138 Medical Supplies, Inc.

K number K000741

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IPF 2001-09-28

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL

Applicant Biomedical Life Systems, Inc.

K number K010749

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IPF 2001-08-24

AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

Applicant Apex Medical Corp.

K number K002339

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IPF 2001-08-09

MUSCLE STIMULATOR SA-100

Applicant Health@Fitness Technologies, Inc.

K number K010807

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IPF 2001-07-27

MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

Applicant Apex Medical Corp.

K number K002336

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IPF 2001-06-27

EMS 3000

Applicant Dan Med, Inc.

K number K010745

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IPF 2001-06-15

NEURO-TRAIN III (3)

Applicant Sterne Equipment Co., Ltd.

K number K003433

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IPF 2001-06-06

SMITH & NEPHEW RESTIM

Applicant Smith & Nephew, Inc.

K number K003596

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IPF 2001-06-06

FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE

Applicant Dysphagia, LLC

K number K002410

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IPF 2001-05-29

VECTORSURGE 5, MODEL VS-500

Applicant Metron Medical Australia, Pty, Ltd.

K number K002058

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IPF 2001-04-27

TRANSAMERICA DIGITAL EMS

Applicant Transamerica Medical Systems

K number K010665

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