510(k) Report

Devices descending from K040367

6 later devices reach Medpulse Respiratory Vest System, Model 2000EZ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053248Smartvest Airway Clearance System, Model TLElectromed, Inc.20055—
+2K132794Smartvest Airway Clearance SystemElectromed, Inc.20131—
+2K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation20132—
+3K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical20260—
+3K250860BreatheBand® (Model 1000)Exemplar Medical, LLC20250—
+3K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.20220—