K Number
Device Name
Decision Date
Decision
Applicant
Vecttor VT-300
Feb 08, 2024
Substantially Equivalent
Artaflex Inc.
ETD4000
Mar 26, 2021
Substantially Equivalent
TheraSigma, LLC
Avid IF2
Jun 12, 2019
Substantially Equivalent
Vision Quest Industries Inc./ dba VQ OrthoCare
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
Dec 21, 2012
Substantially Equivalent
GEMORE TECHNOLOGY CO., LTD.
VECTTOR VT-200
Nov 21, 2012
Substantially Equivalent
ALAN NEUROMEDICAL TECHNOLOGIES LLC
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
Jun 20, 2011
Substantially Equivalent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
MAX-IF1000
Nov 24, 2010
Substantially Equivalent
BIO PROTECH, INC.
INF 4160 PLUS, MODEL D-FJ31F
Jan 07, 2010
Substantially Equivalent
FUJI DYNAMICS LIMITED
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
Oct 08, 2009
Substantially Equivalent
WELL-LIFE HEALTHCARE LIMITED
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
Jan 30, 2009
Substantially Equivalent
WELL-LIFE HEALTHCARE LIMITED
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
Jun 29, 2007
Substantially Equivalent
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
May 10, 2006
Substantially Equivalent
THERATECH, INC.
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
Dec 13, 2005
Substantially Equivalent
BIOWAVE CORPORATION
INF 4160, MODEL D-FJ27F
Feb 11, 2005
Substantially Equivalent
FUJI DYNAMICS LIMITED
INFINITY ELECTROTHERAPY SYSTEM
Dec 17, 2004
Substantially Equivalent
EMPI
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
Jul 07, 2004
Substantially Equivalent
BIOMEDICAL LIFE SYSTEMS, INC.
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
Apr 29, 2004
Substantially Equivalent
BIOMEDICAL LIFE SYSTEMS, INC.
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
Dec 10, 2003
Substantially Equivalent
GEMORE TECHNOLOGY CO., LTD.
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
Nov 14, 2003
Substantially Equivalent
SURGITECH, INC.
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
Feb 25, 2003
Substantially Equivalent
THERATECH, INC.
NEOGENESYS 2K
Jan 24, 2003
Substantially Equivalent
SANEXAS INTL. GMBH
CARE IFC PLUS
May 16, 2002
Substantially Equivalent
CARE REHAB, INC.
MEDSTAR 100 INTERFERENTIAL STIMLATOR
Nov 16, 2001
Substantially Equivalent
MEDNET SERVICES, INC.
SMARTWAVE IF 2000
Aug 10, 2001
Substantially Equivalent
NEWWAVE MEDICAL LLC.
DYNATRON STS
May 15, 2001
Substantially Equivalent
DYNATRONICS CORP.
DYNATRON STS RX
May 15, 2001
Substantially Equivalent
DYNATRONICS CORP.
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
Feb 05, 2001
Substantially Equivalent
NISHA COMMUNICATION INDUSTRIES
SD-730 IF-SDS, PERFECT PULSE IF-SDS
Feb 03, 2000
Substantially Equivalent
SKYLARK DEVICE & SYSTEMS CO., LTD
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
Apr 12, 1999
Substantially Equivalent
THERAPY LINK, INC.
IF-727 INTERFERENTIAL STIMULATOR
Mar 06, 1998
Substantially Equivalent
SKYLARK DEVICE CO., LTD.
APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
Apr 01, 1997
Substantially Equivalent
WHOLESALE MEDICAL IMPORTS, INC.
DYNATRON 525
Sep 05, 1996
Substantially Equivalent
DYNATRONICS CORP.
MULTI III, IV
Mar 22, 1996
Substantially Equivalent for Some Indications
EXCEL TECH. LTD.
ISOTRON III, ISOTRON IV
Mar 22, 1996
Substantially Equivalent for Some Indications
EXCEL TECH. LTD.
DYNATRON 950
Sep 13, 1995
Substantially Equivalent for Some Indications
DYNATRONICS CORP.
DYNATRON 650
Sep 13, 1995
Substantially Equivalent for Some Indications
DYNATRONICS CORP.
DYNATRON 850
Sep 01, 1995
Substantially Equivalent for Some Indications
DYNATRONICS RESEARCH CORP.
DYNATRON 550
Sep 01, 1995
Substantially Equivalent for Some Indications
DYNATRONICS CORP.
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
Aug 11, 1995
Substantially Equivalent for Some Indications
RICH-MAR CORP.
CMT-1000
May 23, 1995
Substantially Equivalent
EMS, INC.
ISOTRON III
May 03, 1995
Substantially Equivalent for Some Indications
EXCEL TECH. LTD.
THERATOUCH 4.7
Jul 29, 1994
Substantially Equivalent
RICH-MAR CORP.
IF400
Jun 14, 1994
Substantially Equivalent
SKYLARK DEVICE CO., LTD.
MATRIX PRO-ELECDT
Jun 09, 1994
Substantially Equivalent
MATRIX ELECTROMEDICAL, INC.
VIFI: VECTOR INTERFERENTIAL ONE
Mar 10, 1994
Substantially Equivalent
COMPLIANCE TECHNOLOGY, INC.
INTERFERENTIAL CURRENT THERAPY UNIT
Feb 23, 1994
Substantially Equivalent
LUMISCOPE CO., INC.
MATRIX ELECDT & VACUPULLS
Jun 29, 1993
Substantially Equivalent
MATRIX ELECTROMEDICAL, INC.
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
Mar 29, 1993
Substantially Equivalent
BIOMEDICAL LIFE SYSTEMS, INC.
INTELECT IFC2
Mar 05, 1993
Substantially Equivalent
CHATTANOOGA GROUP, INC.
HMP 4000 INTERFERENTIAL STIMULATOR
Feb 25, 1993
Substantially Equivalent
HMP 4000, INC.