510(k) Report

Devices descending from K070541

8 later devices reach Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190251RecoveryRxBioelectronics Corporation20190—
+1K152432ActiPatch (R)Bioelectronics Corporation20171—
+1K121338ZEOBIIvivi Health Science, LLC20120—
+1K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical20093—
+1K091996Orthocor Knee System BasicOrthocor Medical20092—
+2K241395Active System; Avenue8Caerus Corporation20240—
+2K192234ActiPatchBioelectronics Corporation20200—
+2K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical20131—