510(k) Report

Devices descending from K021755

25 later devices reach Apex Medical Digital Tens TS1211, TS1212 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081141Combocare 2000Xanacare Technologies, LLC20086—
+1K071869Tens/IF 14Emsi20080—
+1K071624Everelife Transcutaneous Muscle StimulatorEverlife Medical Equipment Co., Ltd.20070—
+1K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A.20070—
+1K060246InfrexJohari Digital Healthcare, Ltd.200614—
+1K041172Basba E-MachineBasba, Inc.20040—
+2K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+2K142025Neurolumen PN-1000Neurolumen, LLC20150—
+2K083822Laser TouchoneLaser Health Technologies, LLC20091—
+2K083202Combocare 2000Xanacare Technologies, LLC20082—
+2K073438Prostim 1000/2000Bio Protech, Inc.20080—
+2K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation200811—
+3K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC20169—
+3K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+3K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+3K090866Neurocalm Model 1 and 2Neuromed Devices, Inc.20090—
+4K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+4K212859First ReliefDyansys, Inc.20210—
+4K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC20177—
+5K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc.20186—
+6K202660SPRINT PNS SystemSpr Therapeutics, Inc.20215—
+7K213188Primary ReliefDyansys, Inc.20221—
+7K211801SPRINT PNS SystemSpr Therapeutics, Inc.20211—
+8K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.20230—
+8K221425Primary ReliefDyansys, Inc.20220—