510(k) Report

Devices descending from K113010

8 later devices reach FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183074TENS and EMS Stimulator, TENS StimulatorAstek Technology, Ltd.20200—
+1K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd.20186—
+2K210021Axon TherapyNeuralace Medical, Inc.20215—
+3K233364Axon TherapyNeuralace Medical, Inc.20241—
+3K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S20233—
+4K250309BTL-199BTL Industries, Inc.20250—
+4K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited20250—
+4K241785StarFormer (M008-3T)Fotona D.O.O.20250—