510(k) Report

Devices descending from K162828

13 later devices reach Winback Back 3SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232966Fisiowarm 7.0Golden Star Srl20240—
+1K213256ThermoTKZimmer Medizinsysteme GmbH20230—
+1K220014RshockSwims America Corp20230—
+1K214090Back 3 COLORSwims America Corp20222—
+1K211207Diacare 7000Globus Sport and Health Technologies, LLC20220—
+1K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L.20204—
+1K183693Doctor TecarMectronic Medicale S.R.L.20190—
+2K230167BACK 4Swims America Corp20230—
+2K230037BACK 3Swims America Corp20230—
+2K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+3K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+3K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—