510(k) Report

Devices descending from DEN180057

5 later devices reach IB-Stim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241533NeurAxis IB-Stim (01-1020)Neuraxis20242—
+1K230526TEA DeviceTranstimulation Research, Inc.20230—
+1K202940First Relief v1Dyansys, Inc.20200—
+2K250451NeurAxis IB-Stim (01-1020)Neuraxis20251—
+3K252024NeurAxis IB-Stim (01-1020)Neuraxis20250—