Bio-Medical Research, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K203513SLENDERTONE Evolve Abs, Type 735February 10, 2021
DEN170049InnovoNovember 6, 2018
K180688SLENDERTONE CoreFit Abs 8, Type 734October 25, 2018
K161974SLENDERTONE® Connect Abs, Type 570November 1, 2016
K151903Slendertone connect AbsNovember 6, 2015
K112934NEUROTECH RECOVERYJanuary 20, 2012
K112258NEUROTECH PLUSJanuary 9, 2012
K103031BMR FACENovember 10, 2011
K110350KNEEHAB XPAugust 3, 2011
K102614AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40June 3, 2011
K100556SLENDERTONE FLEX MAX, MODEL 517 USAugust 2, 2010
K100320SLENDERTONE SYSTEM ULTRA MODEL E70/X70May 5, 2010
K092791KNEEHAB XP CONTROLLER, MODEL 411December 30, 2009
K092793MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411December 7, 2009
K083105KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411July 24, 2009
K091317LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACKJune 25, 2009
K082190BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298March 11, 2009
K083164SYSTEM-ARMS, MODELS 390, X60December 16, 2008
K082011MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458November 28, 2008
K071666SLENDERTONE ENERVIVE, MODEL 561March 12, 2008