510(k) Report

Devices descending from K200359

8 later devices reach NuEra Tight, NuEra Tight EMS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240178RFG-01Zimmer Medizinsysteme GmbH20240—
+1K230659Zionic AestheticTermosalud20230—
+1K221043Doctor Tecar Plus, Doctor Tecar SmartMectronic Medicale S.R.L.20230—
+1K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L.20214—
+2K241733Hebe (NP0000763)Novasonix Technology S.L.20250—
+2K230755NuEra Tight RF Model OptiStreamBios S.R.L.20230—
+2K223856NuEra Tight RF FamilyBios S.R.L.20230—
+2K223907NuEra Tight RF Model APMD145.M70-USBios S.R.L.20230—