LIH · Interferential Current Therapy
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | LIH |
|---|---|
| Device Name | Interferential Current Therapy |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231575 | Vecttor VT-300 | Artaflex, Inc. | Feb 8, 2024 | SESE |
| K202725 | ETD4000 | Therasigma, LLC | Mar 26, 2021 | SESE |
| K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | Jun 12, 2019 | SESE |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | Gemore Technology Co, Ltd. | Dec 21, 2012 | SESE |
| K121662 | VECTTOR VT-200 | Alan Neuromedical Technologies, LLC | Nov 21, 2012 | SESE |
| K110509 | EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 | Everyway Medical Instruments Co.,Ltd | Jun 20, 2011 | SESE |
| K100246 | MAX-IF1000 | Bio Protech, Inc. | Nov 24, 2010 | SESE |
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | Fuji Dynamics Limited | Jan 7, 2010 | SESE |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | Well-Life Healthcare Limited | Oct 8, 2009 | SESE |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E | Well-Life Healthcare Limited | Jan 30, 2009 | SESE |
| K070890 | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 | Everlife Medical Equipment Co., Ltd. | Jun 29, 2007 | SESE |
| K060975 | IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 | Theratech, Inc. | May 10, 2006 | SESE |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Biowave Corporation | Dec 13, 2005 | SESE |
| K043407 | INF 4160, MODEL D-FJ27F | Fuji Dynamics Limited | Feb 11, 2005 | SESE |
| K042057 | INFINITY ELECTROTHERAPY SYSTEM | Empi | Dec 17, 2004 | SESE |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | Biomedical Life Systems, Inc. | Jul 7, 2004 | SESE |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | Biomedical Life Systems, Inc. | Apr 29, 2004 | SESE |
| K032719 | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) | Gemore Technology Co, Ltd. | Dec 10, 2003 | SESE |
| K033358 | CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 | Surgitech, Inc. | Nov 14, 2003 | SESE |
| K024100 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND | Theratech, Inc. | Feb 25, 2003 | SESE |
Top Applicants
- Dynatronics Corp. — 7 clearances
- Biomedical Life Systems, Inc. — 5 clearances
- Excel Tech. , Ltd. — 5 clearances
- Fuji Dynamics Limited — 2 clearances
- Gemore Technology Co, Ltd. — 2 clearances
