Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LIH — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
410 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231575 | Vecttor VT-300 | Artaflex, Inc. | 2024-02-08 | 253 | 0 |
| K202725 | ETD4000 | Therasigma, LLC | 2021-03-26 | 190 | 0 |
| K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2019-06-12 | 163 | 0 |
| K122944 | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 | 88 | 0 |
| K121662 | VECTTOR VT-200 | Alan Neuromedical Technologies, LLC | 2012-11-21 | 169 | 0 |
| K110509 | EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 | Everyway Medical Instruments Co.,Ltd | 2011-06-20 | 118 | 0 |
| K100246 | MAX-IF1000 | Bio Protech, Inc. | 2010-11-24 | 301 | 0 |
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | Fuji Dynamics Limited | 2010-01-07 | 119 | 0 |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | Well-Life Healthcare Limited | 2009-10-08 | 29 | 0 |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-220 | Well-Life Healthcare Limited | 2009-01-30 | 25 | 0 |
| K070890 | EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 | Everlife Medical Equipment Co., Ltd. | 2007-06-29 | 91 | 0 |
| K060975 | IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & W | Theratech, Inc. | 2006-05-10 | 30 | 0 |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Biowave Corporation | 2005-12-13 | 112 | 0 |
| K043407 | INF 4160, MODEL D-FJ27F | Fuji Dynamics Limited | 2005-02-11 | 63 | 0 |
| K042057 | INFINITY ELECTROTHERAPY SYSTEM | Empi | 2004-12-17 | 140 | 0 |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | Biomedical Life Systems, Inc. | 2004-07-07 | 187 | 0 |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | Biomedical Life Systems, Inc. | 2004-04-29 | 30 | 0 |
| K032719 | GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF | Gemore Technology Co, Ltd. | 2003-12-10 | 99 | 0 |
| K033358 | CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 | Surgitech, Inc. | 2003-11-14 | 25 | 0 |
| K024100 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206 | Theratech, Inc. | 2003-02-25 | 75 | 0 |
| K022433 | NEOGENESYS 2K | Sanexas Intl. GmbH | 2003-01-24 | 183 | 0 |
| K020516 | CARE IFC PLUS | Care Rehab, Inc. | 2002-05-16 | 90 | 0 |
| K013082 | MEDSTAR 100 INTERFERENTIAL STIMLATOR | Mednet Services, Inc. | 2001-11-16 | 63 | 0 |
| K003631 | SMARTWAVE IF 2000 | Newwave Medical, LLC | 2001-08-10 | 259 | 0 |
| K010565 | DYNATRON STS | Dynatronics Corp. | 2001-05-15 | 78 | 0 |
| K010948 | DYNATRON STS RX | Dynatronics Corp. | 2001-05-15 | 47 | 0 |
| K993600 | MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 | Nisha Communication Industries | 2001-02-05 | 469 | 0 |
| K992652 | SD-730 IF-SDS, PERFECT PULSE IF-SDS | Skylark Device & Systems Co., Ltd. | 2000-02-03 | 181 | 0 |
| K990129 | TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURREN | Therapy Link, Inc. | 1999-04-12 | 89 | 0 |
| K974585 | IF-727 INTERFERENTIAL STIMULATOR | Skylark Device Co., Ltd. | 1998-03-06 | 88 | 0 |
| K952683 | APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVIC | Wholesale Medical Imports, Inc. | 1997-04-01 | 659 | 0 |
| K961261 | DYNATRON 525 | Dynatronics Corp. | 1996-09-05 | 156 | 0 |
| K955860 | MULTI III, IV | Excel Tech. , Ltd. | 1996-03-22 | 86 | 0 |
| K955387 | ISOTRON III, ISOTRON IV | Excel Tech. , Ltd. | 1996-03-22 | 121 | 0 |
| K950348 | DYNATRON 650 | Dynatronics Corp. | 1995-09-13 | 229 | 0 |
| K950349 | DYNATRON 950 | Dynatronics Corp. | 1995-09-13 | 229 | 0 |
| K941461 | DYNATRON 850 | Dynatronics Research Corp. | 1995-09-01 | 526 | 0 |
| K941577 | DYNATRON 550 | Dynatronics Corp. | 1995-09-01 | 519 | 0 |
| K952089 | RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, T | Rich-Mar Corp. | 1995-08-11 | 100 | 0 |
| K942428 | CMT-1000 | Ems, Inc. | 1995-05-23 | 368 | 0 |
| K941815 | ISOTRON III | Excel Tech. , Ltd. | 1995-05-03 | 386 | 0 |
| K932868 | THERATOUCH 4.7 | Rich-Mar Corp. | 1994-07-29 | 410 | 0 |
| K930535 | IF400 | Skylark Device Co., Ltd. | 1994-06-14 | 497 | 0 |
| K930263 | MATRIX PRO-ELECDT | Matrix Electromedical, Inc. | 1994-06-09 | 506 | 0 |
| K931732 | VIFI: VECTOR INTERFERENTIAL ONE | Compliance Technology, Inc. | 1994-03-10 | 337 | 0 |
| K931768 | INTERFERENTIAL CURRENT THERAPY UNIT | Lumiscope Co., Inc. | 1994-02-23 | 321 | 0 |
| K930264 | MATRIX ELECDT & VACUPULLS | Matrix Electromedical, Inc. | 1993-06-29 | 161 | 0 |
| K925687 | INTERFERENTIAL STIMULATOR MODEL IMF4150/A | Biomedical Life Systems, Inc. | 1993-03-29 | 137 | 0 |
| K924666 | INTELECT IFC2 | Chattanooga Group, Inc. | 1993-03-05 | 170 | 0 |
| K924961 | HMP 4000 INTERFERENTIAL STIMULATOR | Hmp 4000, Inc. | 1993-02-25 | 148 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda