Bio-Medical Research, Ltd.
Galway, IE
Bio-Medical Research, Ltd. appears in FDA device records in Galway, IE. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 37
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 37 510(k) clearances for Bio-Medical Research, Ltd. between 1984 and 2021. The busiest year on record is 2009, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1996 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 5 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203513 | SLENDERTONE Evolve Abs, Type 735 | NGX | Substantially Equivalent | |
| DEN170049 | Innovo | QAJ | Unknown | |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | NGX | Substantially Equivalent | |
| K161974 | SLENDERTONE® Connect Abs, Type 570 | NGX | Substantially Equivalent | |
| K151903 | Slendertone connect Abs | NGX | Substantially Equivalent | |
| K112934 | NEUROTECH RECOVERY | GXY | Substantially Equivalent | |
| K112258 | NEUROTECH PLUS | GZJ | Substantially Equivalent | |
| K103031 | BMR FACE | NFO | Substantially Equivalent | |
| K110350 | KNEEHAB XP | GZJ | Substantially Equivalent | |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 | GXY | Substantially Equivalent | |
| K100556 | SLENDERTONE FLEX MAX, MODEL 517 US | NGX | Substantially Equivalent | |
| K100320 | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 | NGX | Substantially Equivalent | |
| K092791 | KNEEHAB XP CONTROLLER, MODEL 411 | IPF | Substantially Equivalent | |
| K092793 | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 | GXY | Substantially Equivalent | |
| K083105 | KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 | IPF | Substantially Equivalent | |
| K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK | GZJ | Substantially Equivalent | |
| K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 | GZJ | Substantially Equivalent | |
| K083164 | SYSTEM-ARMS, MODELS 390, X60 | NGX | Substantially Equivalent | |
| K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 | GZJ | Substantially Equivalent | |
| K071666 | SLENDERTONE ENERVIVE, MODEL 561 | NGX | Substantially Equivalent | |
| K072553 | SYSTEM-ARMS, MODEL 390,E60 | NGX | Substantially Equivalent | |
| K072294 | SYSTEM-MINI, MODELS: 390, E30 | NGX | Substantially Equivalent | |
| K070142 | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 | NGX | Substantially Equivalent | |
| K052969 | SLENDERTONE GYMBODY, MODEL 512-01 | NGX | Substantially Equivalent | |
| K024258 | NEUROTECH KNEEHAB | IPF | Substantially Equivalent | |
| K023916 | BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 | GZJ | Substantially Equivalent | |
| K023913 | NEUROTECH BAXOLVE TYPE 294 | GZJ | Substantially Equivalent | |
| K030708 | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 | NGX | Substantially Equivalent | |
| K022855 | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 | NGX | Substantially Equivalent | |
| K014020 | NT MEDITENS PLUS, TYPE 290 | GZJ | Substantially Equivalent | |
| K014019 | NEUROTECH MEDISTIM PLUS, TYPE 291 | IPF | Substantially Equivalent | |
| K010335 | SLENDERTONE FLEX, MODEL, 512 | NGX | Substantially Equivalent | |
| K972244 | NT2000 | GZJ | Substantially Equivalent | |
| K961376 | SMART-TENS, MODEL 456 | GZJ | Substantially Equivalent | |
| K840149 | BMR POWERSTIM | IPF | Substantially Equivalent | |
| K840148 | BMR-16 CLINIC MUSCLE STIMULATOR | IPF | Substantially Equivalent | |
| K840147 | BMR-2 MUSCLE STIMULATOR | IPF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain