LIH · Class II · 21 CFR 882.5890

FDA Product Code LIH: Interferential Current Therapy

Leading manufacturers include Dynatronics Corp., Biomedical Life Systems, Inc. and Excel Tech. , Ltd..

73
Total
73
Cleared
193d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Interferential Current Therapy Devices (Product Code LIH)

73 devices
1–24 of 73
Cleared Feb 08, 2024
Vecttor VT-300
K231575
Artaflex, Inc.
Neurology · 253d
Cleared Mar 26, 2021
ETD4000
K202725
Therasigma, LLC
Neurology · 190d
Cleared Jun 12, 2019
Avid IF2
K183692
Vision Quest Industries Inc./Dba VQ Orthocare
Neurology · 163d
Cleared Dec 21, 2012
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
K122944
Gemore Technology Co, Ltd.
Neurology · 88d
Cleared Nov 21, 2012
VECTTOR VT-200
K121662
Alan Neuromedical Technologies, LLC
Neurology · 169d
Cleared Jun 20, 2011
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K110509
Everyway Medical Instruments Co.,Ltd
Neurology · 118d
Cleared Nov 24, 2010
MAX-IF1000
K100246
Bio Protech, Inc.
Neurology · 301d
Cleared Jan 07, 2010
INF 4160 PLUS, MODEL D-FJ31F
K092780
Fuji Dynamics Limited
Neurology · 119d
Cleared Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763
Well-Life Healthcare Limited
Neurology · 29d
Cleared Jan 30, 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023
Well-Life Healthcare Limited
Neurology · 25d
Cleared Jun 29, 2007
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890
Everlife Medical Equipment Co., Ltd.
Neurology · 91d
Cleared May 10, 2006
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K060975
Theratech, Inc.
Neurology · 30d
Cleared Dec 13, 2005
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K052289
Biowave Corporation
Neurology · 112d
Cleared Feb 11, 2005
INF 4160, MODEL D-FJ27F
K043407
Fuji Dynamics Limited
Neurology · 63d
Cleared Dec 17, 2004
INFINITY ELECTROTHERAPY SYSTEM
K042057
Empi
Neurology · 140d
Cleared Jul 07, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007
Biomedical Life Systems, Inc.
Neurology · 187d
Cleared Apr 29, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824
Biomedical Life Systems, Inc.
Neurology · 30d
Cleared Dec 10, 2003
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719
Gemore Technology Co, Ltd.
Neurology · 99d
Cleared Nov 14, 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358
Surgitech, Inc.
Neurology · 25d
Cleared Feb 25, 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K024100
Theratech, Inc.
Neurology · 75d
Cleared Jan 24, 2003
NEOGENESYS 2K
K022433
Sanexas Intl. GmbH
Neurology · 183d
Cleared May 16, 2002
CARE IFC PLUS
K020516
Care Rehab, Inc.
Neurology · 90d
Cleared Nov 16, 2001
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082
Mednet Services, Inc.
Neurology · 63d
Cleared Aug 10, 2001
SMARTWAVE IF 2000
K003631
Newwave Medical, LLC
Neurology · 259d

About Product Code LIH - Regulatory Context

510(k) Submission Activity

73 total 510(k) submissions under product code LIH since 1983, with 73 receiving FDA clearance (average review time: 193 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.