FDA 510(k) Applications for Medical Device Product Code "BYI"
(Percussor, Powered-Electric)

FDA 510(k) Number Applicant Device Name Decision Date
K012928 ADVANCED RESPIRATORY ABI VEST AIRWAY CLEARANCE SYSTEM 10/09/2001
K024309 ADVANCED RESPIRATORY THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 02/21/2003
K842608 ALPHA MEDICAL SYSTEMS INFANT PERCUSSOR PA-010 07/23/1984
K993629 AMERICAN BIOSYSTEMS, INC. ABI VEST AIRWAY CLEARANCE SYSTEM 01/21/2000
K936121 AMERICAN BIOSYSTEMS, INC. THAIRAPY SYSTEM 08/02/1994
K965192 AMERICAN BIOSYSTEMS, INC. THAIRAPY VEST SYSTEM 06/24/1997
K884098 AMERICAN BIOSYSTEMS, INC. THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 12/16/1988
K802646 B & F MEDICAL PRODUCTS, INC. HAND PERCUSSOR CUP #65210 11/12/1980
K860510 BALLARD MEDICAL PRODUCTS NEONATE PERCUSSOR 02/20/1986
K972859 BRADSTREET CLINICAL RESEARCH ASSOC., INC. FLUTTER D 06/05/1998
K946083 BRADSTREET CLINICAL RESEARCH ASSOC., INC. FLUTTER(R) 03/13/1995
K853965 CAS MEDICAL SYSTEMS, INC. NEOGUARD CHEST PERCUSSOR 12/03/1985
K121587 CHEEN HOUNG ENT. CO. LTD. BREATH SHAKE 11/22/2013
K812151 CUSSIONAIR THERAPY PRODUCTS, INC. MJ NEONATAL PERCUSSOR 08/25/1981
K800713 CUSSIONAIR THERAPY PRODUCTS, INC. MJ PERCUSSOR 04/10/1980
K931988 DELTA MEDICAL MANUF, INC. 3P (PULMONARY PERCUSSIVE PACK) 10/28/1994
K812166 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. PERCUSSOR 08/18/1981
K103176 DYMEDSO INC. FREQUENCER 01/26/2011
K100749 DYMEDSO INC. FREQUENCER MODEL V2X 08/31/2010
K063645 DYMEDSO INC. FREQUENCER, MODEL 1001 03/15/2007
K982889 ELECTROMED, INC. MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 06/01/1999
K040367 ELECTROMED, INC. MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ 04/07/2004
K132794 ELECTROMED, INC. SMARTVEST AIRWAY CLEARANCE SYSTEM 12/19/2013
K053248 ELECTROMED, INC. SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL 12/01/2005
K913014 ENGINEERED MEDICAL SYSTEMS EMS PERCUSSOR 10/23/1991
K855129 GENERAL PHYSIOTHERAPY, INC. NEOCUSSOR (MASSAGER, BATTERY) POWERED 01/23/1986
K142482 Hill-Rom Services Private Limited The Vest Airway Clearance System 05/07/2015
K163378 HILL-ROM SERVICES PTE LTD Monarch Airway Clearance System 03/17/2017
K974849 HOUGEN MFG., INC. X-AIR-CISER 08/06/1998
K790675 HUDSON OXYGEN THERAPY SALES CO. 5300 PERCUSSOR 04/18/1979
K812803 HUDSON OXYGEN THERAPY SALES CO. INFANT PERCUSSOR #5534 12/03/1981
K122480 INTERNATIONAL BIOPHYSICS CORPORATION INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST 03/27/2013
K892862 LIFE DESIGN SYSTEMS, INC. FLEX-CUP PERCUSSOR 05/25/1989
K801982 MCSHIRLEY PRODUCTS, INC. THE MCSHIRLEY PERCUSSOR 09/16/1980
K031876 MED SYSTEMS ELECTRO FLO PERCUSSOR, MODEL 5000 11/21/2003
K060439 MEDICAL ACOUSTICS LLC LUNG FLUTE 06/22/2006
K883899 MEDICAL COMPONENTS, INC. MANUAL PERCUSSOR CUPS 12/13/1988
K802399 MEDICAL EQUIPMENT DEVELOPMENT CO., INC. MODEL 2500 PNEUMATIC PERCUSSOR 10/23/1980
K901026 MERCED MEDICAL, INC. MJ PERCUSSOR(TM) 03/15/1990
K880597 MICRO TEK ENGINEERING THUMPER MODEL P-1000 03/29/1988
K121170 RESPINNOVATION SAS RESIN 11 07/13/2012
K051383 RESPIRATORY TECHNOLOGIES, INCORPORATED THE INCOURAGE SYSTEM 06/17/2005
K122111 RESPIRONICS, INC. RESPIRONICS SIMPLYCLEAR DEVICE 12/31/2012
K863658 SALTER LABS SALTER LABS 3000 SERIES PERCUSSORS 10/06/1986
K771876 SHERWOOD MEDICAL INDUSTRIES ARGYLE PEOCUSSOR SYSTEM 10/28/1977
K813438 STROM CORP. PNEUMO PULSSOR 12/29/1981
K821570 STROM CORP. PNEUMO PULSSOR III 06/03/1982
K821265 STROM CORP. PNEUMOPULSSOR (PPS II) 07/26/1982
K882604 TOWER STOPPER, INC. PULMO-PATTY 01/04/1989
K940986 VARIORAW, S.A. FLUTTER(R) 05/24/1994
K133057 Westmed, Inc. VIBRALUNG ACOUSTICAL PERCUSSOR 05/23/2014


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact