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 3 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T | Apex Medical Corp. | 2001-07-27 | Traditional | PDF ↗ |
| K010745 | EMS 3000 | Dan Med, Inc. | 2001-06-27 | Traditional | PDF ↗ |
| K003433 | NEURO-TRAIN III (3) | Sterne Equipment Co., Ltd. | 2001-06-15 | Traditional | PDF ↗ |
| K002410 | FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE | Dysphagia, LLC | 2001-06-06 | Traditional | PDF ↗ |
| K003596 | SMITH & NEPHEW RESTIM | Smith & Nephew, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K002058 | VECTORSURGE 5, MODEL VS-500 | Metron Medical Australia, Pty, Ltd. | 2001-05-29 | Traditional | PDF ↗ |
| K010665 | TRANSAMERICA DIGITAL EMS | Transamerica Medical Systems | 2001-04-27 | Special | PDF ↗ |
| K003260 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 | Metron Medical Australia, Pty, Ltd. | 2001-02-22 | Special | PDF ↗ |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | Rich-Mar Corp. | 2000-08-25 | Traditional | PDF ↗ |
| K000114 | RS-4M+MUSCLE STIMULATOR | Rs Medical | 2000-08-10 | Traditional | PDF ↗ |
| K993420 | CONTROL SOLUTIONS INC, MODEL CS3101 | Control Solutions, Inc. | 2000-07-19 | Traditional | PDF ↗ |
| K994062 | HMS NEUROMUSCULAR STIMULATOR | Home Medical Services, Inc. | 2000-04-10 | Traditional | PDF ↗ |
| K994065 | MS-ONE, MODEL MS-1 | Home Wellness West | 2000-04-04 | Traditional | PDF ↗ |
| K993821 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT | Metron Medical Australia, Pty, Ltd. | 1999-12-09 | Special | PDF ↗ |
| K991241 | IF8000 | Dan Med, Inc. | 1999-11-02 | Traditional | PDF ↗ |
| K990787 | TRIO 300 | Ito Co., Ltd. | 1999-10-20 | Traditional | PDF ↗ |
| K990697 | RS-4V MUSCLE STIMULATOR | Rs Medical | 1999-06-18 | Traditional | PDF ↗ |
| K984142 | SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 | Mettler Electronics Corp. | 1999-02-09 | Traditional | PDF ↗ |
| K984114 | SYS STIM 294, MODEL ME 294 | Mettler Electronics Corp. | 1999-02-09 | Traditional | PDF ↗ |
| K984021 | MS300 | Lsi Intl., Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K984113 | MS400 | Lsi Intl., Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K982828 | FORTE, MODELS CPS 400 STIM, CPS 200 STIM | Chattanooga Group, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K982482 | HANDMASTER NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998-09-30 | Traditional | PDF ↗ |
| K982388 | SURGI STIM | Vision Quest Industries, Inc. | 1998-09-14 | Traditional | PDF ↗ |
| K980158 | MYO-TRAIN V (5) | Sterne Equipment Co., Ltd. | 1998-07-28 | Traditional | PDF ↗ |
| K980040 | ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D | Nisha Communication Industries | 1998-07-13 | Traditional | PDF ↗ |
| K973929 | NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM | Neotonus, Inc. | 1998-05-21 | Traditional | PDF ↗ |
| K980892 | HAKOMED ELECDT / PRO ELEDT SERIES | Alive, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K980958 | HAKOMED ELECDT/VACUPULLS | Alive, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K980346 | ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) | Universal Technology Systems, Inc. | 1998-04-28 | Traditional | PDF ↗ |
| K980448 | MODEL PS-1 PENA MUSCLE STIMULATOR | Radionics, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K973223 | STELLAR MODEL HS-04 | Stellar Medical Corp. | 1998-02-18 | Traditional | PDF ↗ |
| K972997 | AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION | Dan Med, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR | Skylark Device Co., Ltd. | 1997-10-09 | Traditional | PDF ↗ |
| K961751 | W.M.E. GPS 1001 | Weaver Medical Electronics, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K970847 | IMPULSE HVG | Armstrong Industries, Inc. | 1997-09-10 | Traditional | PDF ↗ |
| K972055 | MSI MAGNA-STYM | Microvas Systems, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K971542 | ORTHO DX NEUROMUSCULAR STIMULATOR | Rehabilicare, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K955666 | EGS4000 | S&P Electrical Industries, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K970155 | NEURO-TRAIN II (2) | Sterne Equipment Co., Ltd. | 1997-03-17 | Traditional | PDF ↗ |
| K964028 | SYS STIM 226 | Mettler Electronics Corp. | 1997-02-03 | Traditional | PDF ↗ |
| K964423 | AXIOM INF | Axiom Manufacturing | 1997-01-24 | Traditional | PDF ↗ |
| K950550 | XH-1 NEUROMUSCULAR STIMULATOR | California Medical Research Institute | 1996-12-04 | Traditional | PDF ↗ |
| K962462 | MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR | Smith and Nephew Donjoy, Inc. | 1996-09-23 | Traditional | PDF ↗ |
| K960457 | ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C | Med Labs, Inc. | 1996-09-06 | Traditional | PDF ↗ |
| K952273 | HANDMASTER NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996-05-23 | Traditional | PDF ↗ |
| K955736 | STIM-8 | Bmr , Ltd. | 1996-05-22 | Traditional | PDF ↗ |
| K960433 | VST-10, VST-10/2 | Vcare Intl., Inc. | 1996-05-21 | Traditional | PDF ↗ |
| K955146 | AXIOM-HVG | Axiom Manufacturing | 1996-05-17 | Traditional | PDF ↗ |
| K960096 | ULTRA III | Excel Tech. , Ltd. | 1996-03-27 | Traditional | PDF ↗ |
| K960489 | ULTRA IV | Excel Tech. , Ltd. | 1996-03-27 | Traditional | PDF ↗ |
| K954411 | GALVA-5-M | Zimmer Elektromedizin GmbH | 1996-02-28 | Traditional | PDF ↗ |
| K951682 | OCTOSTIM | Freiler | 1995-12-11 | Traditional | PDF ↗ |
| K952680 | VARAPULSE-2 | Staodyne, Inc. | 1995-12-04 | Traditional | PDF ↗ |
| K953136 | RS-4M | Rs Medical | 1995-11-30 | Traditional | PDF ↗ |
| K951727 | Z-WATCH SYSTEM | Prizm Medical, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K953615 | FORTE ES-400 | Chattanooga Group, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K950783 | 4000+ | U.S. Therapy Products, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K943007 | ITP-HVPC GALVANIC STIMULATOR | Innovative Therapy Products, Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K950617 | SMART WAVE GS100 | Shotwell & Carr, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K942195 | BX-400S | Bloomex International, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K943185 | BX-200 SC | Bloomex International, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K946186 | CHAL-2500 | Hogan & Hartson | 1995-08-14 | Traditional | PDF ↗ |
| K944935 | DYNATRON 250 | Dynatronics Corp. | 1995-06-22 | Traditional | PDF ↗ |
| K946298 | BIOSTIM-HV | Progressive Concepts, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K932075 | MASTERSTIM 1-4 | Health Care Assoc. | 1995-05-10 | Traditional | PDF ↗ |
| K945509 | FX-2 NMS (2CHANNEL TABLE MODEL) | Fx-2 | 1995-05-02 | Traditional | PDF ↗ |
| K945510 | FX-4 NMS (4CHANNEL TABLE MODEL) | Fx-2 | 1995-05-02 | Traditional | PDF ↗ |
| K945508 | FX-2P NMS (2 CHANNEL PORTABLE) | Fx-2 | 1995-05-02 | Traditional | PDF ↗ |
| K940301 | COMPEX 2 | Biodex Medical Systems, Inc. | 1994-12-28 | Traditional | PDF ↗ |
| K934556 | EMS-250 | Electronic Medical Sciences, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K933194 | THE SIGNATURE SERIES, IMC IV | Progressive Electrical Therapeutics | 1994-07-13 | Traditional | PDF ↗ |
| K933196 | THE SIGNATURE SERIES, IC II | Progressive Electrical Therapeutics | 1994-07-12 | Traditional | PDF ↗ |
| K941049 | MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR | Smith & Nephew, Inc. | 1994-05-19 | Traditional | PDF ↗ |
| K934919 | THE SIGNATURE SERIES, MAGNUM 100 | Progressive Electrical Therapeutics | 1994-04-06 | Traditional | PDF ↗ |
| K940349 | NEUROMUSCULAR ELECTRICAL STIMULATOR | Progressive Concepts, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K933653 | MS 2500 | Lsi Intl., Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K931401 | EMS | Saratoga Intl., Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K932898 | POWERED MUSCLE STIMULATOR | Nemectron GmbH | 1994-03-15 | Traditional | PDF ↗ |
| K926084 | HVGS 9000 | Shevlin Medical, Inc. | 1994-03-14 | Traditional | PDF ↗ |
| K933195 | THE SIGNATURE SERIES, IC IV | Progressive Electrical Therapeutics | 1994-02-23 | Traditional | PDF ↗ |
| K932739 | FAST START NEUROMUSCULAR STIMULATOR | Madeoutback Co. , Ltd. | 1994-01-07 | Traditional | PDF ↗ |
| K932916 | GALVANIC GENERATOR MODEL IMF4150/A | Biomedical Life Systems, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K933072 | PCI 2500 | Pci | 1993-10-28 | Traditional | PDF ↗ |
| K933249 | DYNATRON 100 PLUS | Dynatronics Research Corp. | 1993-10-08 | Traditional | PDF ↗ |
| K931781 | JACE TRI-STIM DEVICE | Jace Systems, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K933176 | NEUROTECH 2000 (NT2000) | Bmr Ent., Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K932764 | THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) | Myo/Kinetic Systems, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K932610 | PCI 4000 | Pci | 1993-08-19 | Traditional | PDF ↗ |
| K932596 | NT4-PLUS | Bmr Ent., Inc. | 1993-08-12 | Traditional | PDF ↗ |
| K932399 | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) | Myo/Kinetic Systems, Inc. | 1993-08-11 | Traditional | PDF ↗ |
| K926410 | ULTRATONE 8+ & 20 | Bowater Research, Inc. | 1993-08-11 | Traditional | PDF ↗ |
| K926510 | STAODYN EMS+2 | Staodyne, Inc. | 1993-08-11 | Traditional | PDF ↗ |
| K926265 | NEURO-CARE 1000 | Ems Northwest | 1993-08-03 | Traditional | PDF ↗ |
| K930670 | PHYACTION 787 | Verimed Holdings, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K924699 | PMP MUSCLE STIMULATOR | Preferred Medical Products | 1993-04-30 | Traditional | PDF ↗ |
| K923498 | BIPHASIC UNIT | Willows Health Center | 1993-03-04 | Traditional | PDF ↗ |
| K923501 | HIGH VOLT UNIT | Willows Health Center | 1993-03-04 | Traditional | PDF ↗ |
| K925680 | LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR | M.S.P. , Ltd. | 1993-03-02 | Traditional | PDF ↗ |
| K920388 | RS-1 NEUROMUSCULAR STIMULATOR | Rs Medical | 1993-01-28 | Traditional | PDF ↗ |
Product code IPF · Class II · Physical Medicine. Data: openFDA.