Atlas FDA

LIH

73 FDA 510(k) clearances · Product code

154 daysmedian time to decision
410 days90th percentile
73clearances measured

FDA profile

Official device name
Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 1999: 2 · 2005: 2 · 2008: 14 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Vecttor VT-300 (K231575)Artaflex, Inc.2024-02-08
ETD4000 (K202725)Therasigma, LLC2021-03-26
Avid IF2 (K183692)Vision Quest Industries Inc./Dba VQ Orthocare2019-06-12
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (K122944)Gemore Technology Co, Ltd.2012-12-21
VECTTOR VT-200 (K121662)Alan Neuromedical Technologies, LLC2012-11-21
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (K110509)Everyway Medical Instruments Co.,Ltd2011-06-20
MAX-IF1000 (K100246)Bio Protech, Inc.2010-11-24
INF 4160 PLUS, MODEL D-FJ31F (K092780)Fuji Dynamics Limited2010-01-07
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (K092763)Well-Life Healthcare Limited2009-10-08
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (K090023)Well-Life Healthcare Limited2009-01-30
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (K070890)Everlife Medical Equipment Co., Ltd.2007-06-29
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 (K060975)Theratech, Inc.2006-05-10
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE (K052289)Biowave Corporation2005-12-13
INF 4160, MODEL D-FJ27F (K043407)Fuji Dynamics Limited2005-02-11
INFINITY ELECTROTHERAPY SYSTEM (K042057)Empi2004-12-17
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 (K040007)Biomedical Life Systems, Inc.2004-07-07
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 (K040824)Biomedical Life Systems, Inc.2004-04-29
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) (K032719)Gemore Technology Co, Ltd.2003-12-10
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 (K033358)Surgitech, Inc.2003-11-14
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND (K024100)Theratech, Inc.2003-02-25
NEOGENESYS 2K (K022433)Sanexas Intl. GmbH2003-01-24
CARE IFC PLUS (K020516)Care Rehab, Inc.2002-05-16
MEDSTAR 100 INTERFERENTIAL STIMLATOR (K013082)Mednet Services, Inc.2001-11-16
SMARTWAVE IF 2000 (K003631)Newwave Medical, LLC2001-08-10
DYNATRON STS (K010565)Dynatronics Corp.2001-05-15
DYNATRON STS RX (K010948)Dynatronics Corp.2001-05-15
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 (K993600)Nisha Communication Industries2001-02-05
SD-730 IF-SDS, PERFECT PULSE IF-SDS (K992652)Skylark Device & Systems Co., Ltd.2000-02-03
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR (K990129)Therapy Link, Inc.1999-04-12
IF-727 INTERFERENTIAL STIMULATOR (K974585)Skylark Device Co., Ltd.1998-03-06
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE (K952683)Wholesale Medical Imports, Inc.1997-04-01
DYNATRON 525 (K961261)Dynatronics Corp.1996-09-05
MULTI III, IV (K955860)Excel Tech. , Ltd.1996-03-22
ISOTRON III, ISOTRON IV (K955387)Excel Tech. , Ltd.1996-03-22
DYNATRON 650 (K950348)Dynatronics Corp.1995-09-13
DYNATRON 950 (K950349)Dynatronics Corp.1995-09-13
DYNATRON 850 (K941461)Dynatronics Research Corp.1995-09-01
DYNATRON 550 (K941577)Dynatronics Corp.1995-09-01
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE (K952089)Rich-Mar Corp.1995-08-11
CMT-1000 (K942428)Ems, Inc.1995-05-23
ISOTRON III (K941815)Excel Tech. , Ltd.1995-05-03
THERATOUCH 4.7 (K932868)Rich-Mar Corp.1994-07-29
IF400 (K930535)Skylark Device Co., Ltd.1994-06-14
MATRIX PRO-ELECDT (K930263)Matrix Electromedical, Inc.1994-06-09
VIFI: VECTOR INTERFERENTIAL ONE (K931732)Compliance Technology, Inc.1994-03-10
INTERFERENTIAL CURRENT THERAPY UNIT (K931768)Lumiscope Co., Inc.1994-02-23
MATRIX ELECDT & VACUPULLS (K930264)Matrix Electromedical, Inc.1993-06-29
INTERFERENTIAL STIMULATOR MODEL IMF4150/A (K925687)Biomedical Life Systems, Inc.1993-03-29
INTELECT IFC2 (K924666)Chattanooga Group, Inc.1993-03-05
HMP 4000 INTERFERENTIAL STIMULATOR (K924961)Hmp 4000, Inc.1993-02-25
MASTERSTIM I-2 (K924490)Health Care Assoc.1993-02-05
DYNATRON 400 (K924319)Dynatronics Corp.1993-01-14
POWERED MUSCLE STIMULATOR (K922529)M.S.P. , Ltd.1992-11-16
ENDOMED 582 (K922020)Henley Intl.1992-09-22
BRINDLEY & SMITH ET-1000 (K915100)Zmi Corp.1992-09-14
MEDI-STIM (K921491)Mid-Canada Medical1992-09-03
ISOTRON III (K921954)Excel Tech. , Ltd.1992-08-26
MULTI III (K921953)Excel Tech. , Ltd.1992-08-26
INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2 (K921612)Medstar, Inc.1992-08-18
INTERFERENTIAL STIMULATOR MODEL INF 4150/A (K921441)Biomedical Life Systems, Inc.1992-05-08
LSI SYSTEM II (K904743)M.S.P. , Ltd.1991-09-04
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A (K905571)Biomedical Life Systems, Inc.1991-05-08
NEUROTRAIN (K883896)Sterne Equipment Co., Ltd.1989-07-14
IF-II (TM), MODEL 9800 (K883462)Medical Devices, Inc.1989-05-24
SYS*STIM 220 (K883080)Mettler Electronics Corp.1989-04-27
INTER TRON 4000 (K880924)Diversified Chiropractic Systems1988-10-13
ENDOMED 433 (K870384)Henley Intl.1988-04-13
ELECTROSTIM I.F. (K873566)Promatek Industries, Ltd.1988-02-01
INTERFERENTIAL CURRENT UNIT (K874119)Compustim Electronics1988-01-22
OMNIVAC (VACUUM ELECTRODE SYSTEM) (K861039)Physio Technology, Inc.1986-09-26
NEMECTRODYN MODEL 2 & ENDOVAC 2 (K854721)Nemectron Medical, Inc.1986-03-06
ENDODYNE DUAL (K840321)Elmed, Inc.1984-03-16
VECTOR SEIGE 2023645 AC POWERED STIMU- (K833305)Metronex Engineering1983-11-28

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