510(k) Report

Devices descending from K181688

6 later devices reach R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210021Axon TherapyNeuralace Medical, Inc.20215—
+2K233364Axon TherapyNeuralace Medical, Inc.20241—
+2K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S20233—
+3K250309BTL-199BTL Industries, Inc.20250—
+3K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited20250—
+3K241785StarFormer (M008-3T)Fotona D.O.O.20250—