510(k) Report

Devices descending from K082514

6 later devices reach Tens/Ems Combo, Ems, Tens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092448Hivox Electric Stimulator Tens & Ems, HD2Hivox Biotek, Inc.20100—
+1K100117LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems StimulatorShenzhen Dongdixin Technology Co., Ltd.20104—
+2K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc.20103—
+3K133779CP Relief WandMid-America Medical Innovations, LLC20141—
+3K113544Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation20120—
+4K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC20250—