510(k) Report

Devices descending from K053248

5 later devices reach Smartvest Airway Clearance System, Model TL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132794Smartvest Airway Clearance SystemElectromed, Inc.20131—
+1K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation20132—
+2K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical20260—
+2K250860BreatheBand® (Model 1000)Exemplar Medical, LLC20250—
+2K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.20220—