FDA Product Code
FDA Product Code IPF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5850
510(k) Clearances — 548 records · page 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093324 | EMPI CONTINUUM | Empi | 2010-03-05 | Traditional | PDF ↗ |
| K093138 | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 | Shenzhen Dongdixin Technology Co., Ltd. | 2010-02-12 | Traditional | PDF ↗ |
| K100117 | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-29 | Traditional | PDF ↗ |
| K092791 | KNEEHAB XP CONTROLLER, MODEL 411 | Bio-Medical Research, Ltd. | 2009-12-30 | Special | PDF ↗ |
| K093259 | ARP RX100 | Arp Manufacturing, Inc. | 2009-12-17 | Traditional | PDF ↗ |
| K091248 | MAXEMS, MODELS 1000 AND 2000 | Bio Protech, Inc. | 2009-11-30 | Traditional | PDF ↗ |
| K090532 | T.E.A.R. TECH3 | Vision Quest Industries, Inc. | 2009-11-13 | Traditional | PDF ↗ |
| K083105 | KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 | Bio-Medical Research, Ltd. | 2009-07-24 | Traditional | PDF ↗ |
| K090632 | COMPEX REHAB | Chattanooga Group | 2009-06-01 | Traditional | PDF ↗ |
| K080950 | STIWELL MED4 | Otto Bock, Austria GmbH | 2009-04-02 | Traditional | PDF ↗ |
| K071677 | SRT II MUSCLE STIMULATOR | Therapeutic Innovations, Inc. | 2008-07-11 | Traditional | PDF ↗ |
| K070888 | COMBI 8 MAX | Cec Electronica S.R.L. | 2008-07-03 | Abbreviated | PDF ↗ |
| K080787 | BIOMOVE 5000 SYSTEM | Curatronic, Ltd. | 2008-04-17 | Special | PDF ↗ |
| K080661 | MODELS TENS 7000, EMS 7500 AND TWIN STIM | Koalaty Products, Inc. | 2008-03-24 | Traditional | PDF ↗ |
| K073361 | MUSCLE PAIN DEVICE (MPD) | Stevens Proof of Concept, Inc. | 2008-03-18 | Traditional | PDF ↗ |
| K072252 | VEINOPLUS NEUROMUSCULAR STIMULATOR | Ad Rem Technology Sarl | 2008-01-30 | Traditional | PDF ↗ |
| K063642 | FD EMS, MODEL # D-FJ30E | Fuji Dynamics Limited | 2007-12-13 | Traditional | PDF ↗ |
| K071093 | SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 | San Shih Electrical Enterprise Co., Ltd. | 2007-12-06 | Traditional | PDF ↗ |
| K072795 | MODELS EMS 5.0, EMS 5.1 | Koalaty Products, Inc. | 2007-11-27 | Traditional | PDF ↗ |
| K071431 | GLOBUS GENESY 1100 STIMULATOR | Domino S.R.L. | 2007-09-21 | Traditional | PDF ↗ |
| K071320 | EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 | Everlife Medical Equipment Co., Ltd. | 2007-08-17 | Traditional | PDF ↗ |
| K070425 | VITALSTIM EXPERIA | Chattanooga Group | 2007-06-11 | Traditional | PDF ↗ |
| K062453 | KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 | Kingly Star Intl. Technology Co., Ltd. | 2007-04-17 | Traditional | PDF ↗ |
| K062354 | VECTRA GENISYS VMS FR | Encore Medical L.P. | 2007-01-26 | Traditional | PDF ↗ |
| K053285 | MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM | Durtech System Corp. | 2006-01-05 | Traditional | PDF ↗ |
| K053266 | MYOTRAC INFINITI | Thought Technology , Ltd. | 2005-12-29 | Traditional | PDF ↗ |
| K050921 | EASYSTIM NMS-28 | Easy Med Instrument Co., Ltd. | 2005-12-12 | Abbreviated | PDF ↗ |
| K051135 | AXIOM NVP8500 | Axiom Worldwide, Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K050687 | AXIOM EPS8000 | Axiom Worldwide, Inc. | 2005-07-28 | Traditional | PDF ↗ |
| K050847 | IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A | Theratech, Inc. | 2005-06-17 | Special | PDF ↗ |
| K050595 | FT2000 SEQUENCER FOR MUSCLE STIMULATOR | Midwest Development | 2005-05-23 | Traditional | PDF ↗ |
| K050046 | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S | Compex Technologies, Inc. | 2005-04-13 | Traditional | PDF ↗ |
| K024258 | NEUROTECH KNEEHAB | Bio-Medical Research, Ltd. | 2005-03-04 | Traditional | PDF ↗ |
| K041390 | DIAMOND MEDISTIM | Diamond Systems USA, Inc. | 2005-02-09 | Traditional | PDF ↗ |
| K042650 | BIOMOVE 3000 | Curatronic, Ltd. | 2005-01-27 | Traditional | PDF ↗ |
| K041920 | INFINITY PLUS ELECTROTHERAPY SYSTEM | Empi | 2005-01-21 | Traditional | PDF ↗ |
| K041063 | SMARTWAVE MS 2000 | Newwave Medical, LLC | 2004-12-01 | Traditional | PDF ↗ |
| K034005 | SDS-4I | Skylark Device & Systems Co., Ltd. | 2004-11-18 | Traditional | PDF ↗ |
| K042881 | PMD-2000 INTERFERENTIAL STIMULATOR | Phoenix Medical Devices, LLC | 2004-11-18 | Traditional | PDF ↗ |
| K040849 | MENTAMOVE | Cole & Associates | 2004-10-01 | Traditional | PDF ↗ |
| K032954 | ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 | Danmeter A/S | 2004-08-09 | Abbreviated | PDF ↗ |
| K033174 | BMLS03-3 | Biomedical Life Systems, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K041146 | CONTROL SOLUTIONS, INC., MODEL CS3102 HVG | Control Solutions, Inc. | 2004-06-08 | Traditional | PDF ↗ |
| K031310 | TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR | Tai Sheng Electrical Machinery Co., Ltd. | 2004-04-12 | Traditional | PDF ↗ |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | Biomedical Life Systems, Inc. | 2004-03-23 | Traditional | PDF ↗ |
| K032955 | AUTOMOVE, MODEL AM800 | Danmeter A/S | 2003-12-15 | Abbreviated | PDF ↗ |
| K033544 | ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 | Everyway Medical Instruments Co.,Ltd | 2003-12-10 | Special | PDF ↗ |
| K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 | Besmed Health Business Corp | 2003-11-20 | Traditional | PDF ↗ |
| K031820 | ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 | Multinational | 2003-11-12 | Traditional | PDF ↗ |
| K023000 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES | Home Care Technology Co., Ltd. | 2003-10-29 | Traditional | PDF ↗ |
| K033140 | NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P | Everyway Medical Instruments Co.,Ltd | 2003-10-29 | Special | PDF ↗ |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Rich-Mar Corp. | 2003-10-22 | Special | PDF ↗ |
| K032178 | RHYTHM TOUCH Q 2-WAY | Shockim Enterprises, Ltd. | 2003-10-15 | Traditional | PDF ↗ |
| K030998 | MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 | Healthonics, Inc. | 2003-10-10 | Traditional | PDF ↗ |
| K032652 | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | 2003-09-12 | Traditional | PDF ↗ |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | Biomedical Life Systems, Inc. | 2003-08-19 | Traditional | PDF ↗ |
| K020478 | ELECTROMEDICARIN 900 | Electromedicarin, S.A. | 2003-07-17 | Abbreviated | PDF ↗ |
| K030403 | CEFAR REHAB 2 AND REHAB 2 PRO | Cefar Medical AB | 2003-07-17 | Traditional | PDF ↗ |
| K031884 | INTERFERENTIAL STIMULATOR, MODEL NETWAVE | Ryan Telemedicine | 2003-06-30 | Traditional | PDF ↗ |
| K024181 | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM | Prizm Medical, Inc. | 2003-06-26 | Traditional | PDF ↗ |
| K023036 | CARE ETS | Care Rehab and Orthopaedic | 2003-06-19 | Traditional | PDF ↗ |
| K031017 | SYS*STIM 208 AND 208A | Mettler Electronics Corp. | 2003-05-30 | Traditional | PDF ↗ |
| K022998 | HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 | Home Care Technology Co., Ltd. | 2003-05-20 | Traditional | PDF ↗ |
| K030507 | T.E.A.R. TECH3 MODEL #44TT03 | Vision Quest Industries, Inc. | 2003-05-20 | Traditional | PDF ↗ |
| K023230 | ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 | Western Clinical Technology Systems, Inc. | 2003-05-05 | Traditional | PDF ↗ |
| K023001 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L | Home Care Technology Co., Ltd. | 2003-04-08 | Traditional | PDF ↗ |
| K030648 | VECTORSURGE 5 MODEL 470 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 | Special | PDF ↗ |
| K023997 | TENSCARE ULTIMA NMS/EMS | Tenscare, Ltd. | 2003-03-03 | Traditional | PDF ↗ |
| K030254 | INTERFERENTIAL STIMULATOR, MODEL RTM1000 | Ryan Telemedicine | 2003-02-26 | Traditional | PDF ↗ |
| K021588 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 | Biomedical Life Systems, Inc. | 2003-02-13 | Traditional | PDF ↗ |
| K023446 | MEDS-3 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | Traditional | PDF ↗ |
| K023439 | MEDS-4 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | Traditional | PDF ↗ |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | Johari Digital Healthcare , Ltd. | 2002-12-20 | Special | PDF ↗ |
| K023347 | VITAL STIM | Chattanooga Group | 2002-12-06 | Traditional | PDF ↗ |
| K020130 | ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M | Rolor Electronics Corp. | 2002-12-02 | Traditional | PDF ↗ |
| K020750 | DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS | Everyway Medical Instruments Co.,Ltd | 2002-10-31 | Abbreviated | PDF ↗ |
| K022493 | EMS 400 | Body Clock Health Care, Ltd. | 2002-10-11 | Traditional | PDF ↗ |
| K022776 | NESS SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2002-09-11 | Special | PDF ↗ |
| K022175 | P4 PHYSIO | Valmed Corp. | 2002-09-09 | Traditional | PDF ↗ |
| K021905 | CLASSIC NMS | Care Rehab, Inc. | 2002-09-05 | Traditional | PDF ↗ |
| K021472 | HMS-DHR-3 NEUROMUSCULAR STIMULATOR | Home Medical Services | 2002-08-06 | Traditional | PDF ↗ |
| K014019 | NEUROTECH MEDISTIM PLUS, TYPE 291 | Bio-Medical Research, Ltd. | 2002-07-11 | Traditional | PDF ↗ |
| K013768 | POWERED MUSCLE STIMULATOR | Theratech, Inc. | 2002-07-03 | Traditional | PDF ↗ |
| K021754 | APEX MEDICAL DIGITAL EMS TS1311, TS1312 | Apex Medical Corp. | 2002-06-28 | Special | PDF ↗ |
| K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | Empi | 2002-06-18 | Traditional | PDF ↗ |
| K021763 | RS2MI MUSCLE STIMULATOR FAMILY | Rs Medical | 2002-06-13 | Traditional | PDF ↗ |
| K020637 | SELECT STIM | Care Rehab and Orthopaedic | 2002-05-28 | Traditional | PDF ↗ |
| K020684 | FINESUN EMS STIMULATOR | Finesun Worldwide Intl. Co., Ltd. | 2002-05-23 | Traditional | PDF ↗ |
| K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 | Well-Life Healthcare, Inc. | 2002-04-30 | Traditional | PDF ↗ |
| K011588 | SURETONE | Suretone International | 2002-03-28 | Traditional | PDF ↗ |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Rich-Mar Corp. | 2002-01-18 | Special | PDF ↗ |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Rich-Mar Corp. | 2002-01-18 | Special | PDF ↗ |
| K992099 | BIO SPA INTELLIGENT | Starbene | 2002-01-18 | Traditional | PDF ↗ |
| K013081 | MEDSTAR 150 | Mednet Services, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K012885 | NEUROMOVE NM900 | Dan Med, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K011913 | SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES | Sun-Rain System Corp. | 2001-10-26 | Traditional | PDF ↗ |
| K000741 | EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 | 138 Medical Supplies, Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K010749 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL | Biomedical Life Systems, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 | Apex Medical Corp. | 2001-08-24 | Traditional | PDF ↗ |
| K010807 | MUSCLE STIMULATOR SA-100 | Health@Fitness Technologies, Inc. | 2001-08-09 | Traditional | PDF ↗ |
Product code IPF · Class II · Physical Medicine. Data: openFDA.