510(k) Report

Devices descending from K961376

7 later devices reach Smart-Tens, Model 456 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023916BMR Neurotech Back Tens and Lumbar Support Device. Type 294Bio-Medical Research, Ltd.20040—
+1K023913Neurotech Baxolve Type 294Bio-Medical Research, Ltd.20035—
+2K082190Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298Bio-Medical Research, Ltd.20094—
+3K112934Neurotech RecoveryBio-Medical Research, Ltd.20120—
+3K091317Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd.20092—
+4K102614Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd.20110—
+4K092793Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd.20090—