Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Medical Research, Ltd. · Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
394 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203513 | SLENDERTONE Evolve Abs, Type 735 | Bio-Medical Research, Ltd. | 2021-02-10 | 72 | 0 |
| DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018-11-06 | 414 | 0 |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | Bio-Medical Research, Ltd. | 2018-10-25 | 224 | 0 |
| K161974 | SLENDERTONEĀ® Connect Abs, Type 570 | Bio-Medical Research, Ltd. | 2016-11-01 | 106 | 0 |
| K151903 | Slendertone connect Abs | Bio-Medical Research, Ltd. | 2015-11-06 | 119 | 0 |
| K112934 | NEUROTECH RECOVERY | Bio-Medical Research, Ltd. | 2012-01-20 | 109 | 0 |
| K112258 | NEUROTECH PLUS | Bio-Medical Research, Ltd. | 2012-01-09 | 157 | 0 |
| K103031 | BMR FACE | Bio-Medical Research, Ltd. | 2011-11-10 | 394 | 0 |
| K110350 | KNEEHAB XP | Bio-Medical Research, Ltd. | 2011-08-03 | 177 | 0 |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 4 | Bio-Medical Research, Ltd. | 2011-06-03 | 266 | 0 |
| K100556 | SLENDERTONE FLEX MAX, MODEL 517 US | Bio-Medical Research, Ltd. | 2010-08-02 | 154 | 0 |
| K100320 | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 | Bio-Medical Research, Ltd. | 2010-05-05 | 90 | 0 |
| K092791 | KNEEHAB XP CONTROLLER, MODEL 411 | Bio-Medical Research, Ltd. | 2009-12-30 | 110 | 0 |
| K092793 | MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 | Bio-Medical Research, Ltd. | 2009-12-07 | 87 | 0 |
| K083105 | KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 | Bio-Medical Research, Ltd. | 2009-07-24 | 277 | 0 |
| K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK | Bio-Medical Research, Ltd. | 2009-06-25 | 52 | 0 |
| K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT | Bio-Medical Research, Ltd. | 2009-03-11 | 219 | 0 |
| K083164 | SYSTEM-ARMS, MODELS 390, X60 | Bio-Medical Research, Ltd. | 2008-12-16 | 50 | 0 |
| K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 | Bio-Medical Research, Ltd. | 2008-11-28 | 136 | 0 |
| K072553 | SYSTEM-ARMS, MODEL 390,E60 | Bio-Medical Research, Ltd. | 2007-12-14 | 95 | 0 |
| K072294 | SYSTEM-MINI, MODELS: 390, E30 | Bio-Medical Research, Ltd. | 2007-10-25 | 70 | 0 |
| K052969 | SLENDERTONE GYMBODY, MODEL 512-01 | Bio-Medical Research, Ltd. | 2005-11-16 | 26 | 0 |
| K024258 | NEUROTECH KNEEHAB | Bio-Medical Research, Ltd. | 2005-03-04 | 802 | 0 |
| K023916 | BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 | Bio-Medical Research, Ltd. | 2004-04-15 | 507 | 0 |
| K023913 | NEUROTECH BAXOLVE TYPE 294 | Bio-Medical Research, Ltd. | 2003-08-25 | 273 | 0 |
| K030708 | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 | Bio-Medical Research, Ltd. | 2003-06-25 | 111 | 0 |
| K022855 | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 | Bio-Medical Research, Ltd. | 2003-03-06 | 191 | 0 |
| K014020 | NT MEDITENS PLUS, TYPE 290 | Bio-Medical Research, Ltd. | 2002-07-11 | 217 | 0 |
| K014019 | NEUROTECH MEDISTIM PLUS, TYPE 291 | Bio-Medical Research, Ltd. | 2002-07-11 | 217 | 0 |
| K010335 | SLENDERTONE FLEX, MODEL, 512 | Bio-Medical Research, Ltd. | 2001-09-27 | 237 | 0 |
| K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998-02-27 | 256 | 0 |
| K961376 | SMART-TENS, MODEL 456 | Bio-Medical Research, Ltd. | 1996-09-12 | 157 | 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