Company · IE
Bio-Medical Research, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2021. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 15 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 |
| IPF | Stimulator, Muscle, Powered | 7 |
| GXY | Electrode, Cutaneous | 3 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 |
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2021 | K203513 | SLENDERTONE Evolve Abs, Type 735 Bio-Medical Research, Ltd., IE | NGX |
| Nov 6, 2018 | DEN170049 | Innovo Bio-Medical Research, Ltd., IE | QAJ |
| Oct 25, 2018 | K180688 | SLENDERTONE CoreFit Abs 8, Type 734 Bio-Medical Research, Ltd., IE | NGX |
| Nov 1, 2016 | K161974 | SLENDERTONE® Connect Abs, Type 570 Bio-Medical Research, Ltd., IE | NGX |
| Nov 6, 2015 | K151903 | Slendertone connect Abs Bio-Medical Research, Ltd., IE | NGX |
| Jan 20, 2012 | K112934 | NEUROTECH RECOVERY Bio-Medical Research, Ltd., IE | GXY |
| Jan 9, 2012 | K112258 | NEUROTECH PLUS Bio-Medical Research, Ltd., IE | GZJ |
| Nov 10, 2011 | K103031 | BMR FACE Bio-Medical Research, Ltd., IE | NFO |
| Aug 3, 2011 | K110350 | KNEEHAB XP Bio-Medical Research, Ltd., IE | GZJ |
| Jun 3, 2011 | K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 Bio-Medical Research, Ltd., IE | GXY |
| Aug 2, 2010 | K100556 | SLENDERTONE FLEX MAX, MODEL 517 US Bio-Medical Research, Ltd., IE | NGX |
| May 5, 2010 | K100320 | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 Bio-Medical Research, Ltd., IE | NGX |
| Dec 30, 2009 | K092791 | KNEEHAB XP CONTROLLER, MODEL 411 Bio-Medical Research, Ltd., IE | IPF |
| Dec 7, 2009 | K092793 | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 Bio-Medical Research, Ltd., IE | GXY |
| Jul 24, 2009 | K083105 | KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 Bio-Medical Research, Ltd., IE | IPF |
| Jun 25, 2009 | K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK Bio-Medical Research, Ltd., IE | GZJ |
| Mar 11, 2009 | K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 Bio-Medical Research, Ltd., IE | GZJ |
| Dec 16, 2008 | K083164 | SYSTEM-ARMS, MODELS 390, X60 Bio-Medical Research, Ltd., IE | NGX |
| Nov 28, 2008 | K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 Bio-Medical Research, Ltd., IE | GZJ |
| Mar 12, 2008 | K071666 | SLENDERTONE ENERVIVE, MODEL 561 Bio-Medical Research Corp., IE | NGX |
| Dec 14, 2007 | K072553 | SYSTEM-ARMS, MODEL 390,E60 Bio-Medical Research, Ltd., IE | NGX |
| Oct 25, 2007 | K072294 | SYSTEM-MINI, MODELS: 390, E30 Bio-Medical Research, Ltd., IE | NGX |
| Mar 23, 2007 | K070142 | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 Bio-Medical Research Corp., IE | NGX |
| Nov 16, 2005 | K052969 | SLENDERTONE GYMBODY, MODEL 512-01 Bio-Medical Research, Ltd., IE | NGX |
| Mar 4, 2005 | K024258 | NEUROTECH KNEEHAB Bio-Medical Research, Ltd., IE | IPF |
| Apr 15, 2004 | K023916 | BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 Bio-Medical Research, Ltd., IE | GZJ |
| Aug 25, 2003 | K023913 | NEUROTECH BAXOLVE TYPE 294 Bio-Medical Research, Ltd., IE | GZJ |
| Jun 25, 2003 | K030708 | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 Bio-Medical Research, Ltd., IE | NGX |
| Mar 6, 2003 | K022855 | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 Bio-Medical Research, Ltd. | NGX |
| Jul 11, 2002 | K014020 | NT MEDITENS PLUS, TYPE 290 Bio-Medical Research, Ltd., IE | GZJ |
| Jul 11, 2002 | K014019 | NEUROTECH MEDISTIM PLUS, TYPE 291 Bio-Medical Research, Ltd., IE | IPF |
| Sep 27, 2001 | K010335 | SLENDERTONE FLEX, MODEL, 512 Bio-Medical Research, Ltd. | NGX |
| Feb 27, 1998 | K972244 | NT2000 Bio-Medical Research, Ltd. | GZJ |
| Sep 12, 1996 | K961376 | SMART-TENS, MODEL 456 Bio-Medical Research, Ltd. | GZJ |
| Jan 30, 1984 | K840149 | BMR POWERSTIM Bio-Medical Research Corp. | IPF |
| Jan 30, 1984 | K840148 | BMR-16 CLINIC MUSCLE STIMULATOR Bio-Medical Research Corp. | IPF |
| Jan 30, 1984 | K840147 | BMR-2 MUSCLE STIMULATOR Bio-Medical Research Corp. | IPF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||