510(k) Report

Devices descending from K965192

23 later devices reach Thairapy Vest System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation20132—
+1K063645Frequencer, Model 1001Dymedso, Inc.20073—
+1K993629Abi Vest Airway Clearance SystemAmerican Biosystems, Inc.200019—
+2K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical20260—
+2K250860BreatheBand® (Model 1000)Exemplar Medical, LLC20250—
+2K133057Vibralung Acoustical PercussorWestmed, Inc.20140—
+2K100749Frequencer Model V2XDymedso, Inc.20102—
+2K024309The Vest Airway Clearance System, Model 104Advanced Respiratory200313—
+2K012928Abi Vest Airway Clearance SystemAdvanced Respiratory200118—
+3K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited20155—
+3K122111Respironics Simplyclear DeviceRespironics, Inc.20124—
+3K121170RESIN 11Respinnovation Sas20120—
+3K103176FrequencerDymedso, Inc.20111—
+3K051383The Incourage SystemRespiratory Technologies, Incorporated20050—
+4K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc.20240—
+4K242063LibAirty Airway Clearance SystemSynchrony Medical, Ltd.20240—
+4K233441The Vest APX System (PVAPX1)Baxter Healthcare Corportation20240—
+4K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd.201721
+4K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl20141—
+4K140605Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug PercDima Italia Srl20140—
+5K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.20260—
+5K173603Monarch Airway Clearance SystemHill-Rom Holdings, Inc.20181—
+6K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.20210—