FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K140772 |
Actegy Ltd |
AEROSURE MEDIC |
12/19/2014 |
K172388 |
Advanced Circulatory System, a wholly owned subsidiary of |
VPOD ITPR |
12/22/2017 |
K070490 |
ADVANCED CIRCULATORY SYSTEMS, INC. |
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) |
06/20/2007 |
K040084 |
ADVANCED CIRCULATORY SYSTEMS, INC. |
LIFESTYLE CIRCULATORY ENHANCER |
04/07/2004 |
K033401 |
ADVANCED CIRCULATORY SYSTEMS, INC. |
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER |
11/20/2003 |
K133873 |
BESMED HEALTH BUSINESS CORP. |
TRIBALL INCENTIVE SPIROMETER |
04/04/2014 |
K141355 |
BESMED HEALTH BUSINESS CORPORATION |
VOLUMETRIC INCENTIVE SPIROMETER |
09/03/2014 |
K022906 |
CPRX LLC |
RESQPOD CIRCULATORY ENHANCER |
06/11/2003 |
K160636 |
D R BURTON HEALTHCARE LLC |
iPEP System and vPEP |
08/03/2016 |
K192000 |
D R Burton Healthcare, LLC |
D R Burton OxyPAP |
02/19/2020 |
K970596 |
DHD DIEMOLDING HEALTHCARE DIV. |
DHD EMERALD PRODUCT |
05/16/1997 |
K002768 |
DHD HEALTHCARE CORP. |
ACAPELLA |
12/05/2000 |
K991300 |
DHD HEALTHCARE CORP. |
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE |
07/12/1999 |
K003146 |
DHD HEALTHCARE CORP. |
CLINIFLO INCENTIVE SPIROMETER |
11/21/2000 |
K991561 |
DHD HEALTHCARE CORP. |
ROADRUNNER, PEP THERAPY DEVICE |
11/10/1999 |
K983467 |
DHD HEALTHCARE CORP. |
THERAPEP |
04/02/1999 |
K962749 |
DIEMOLDING CORP. |
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT |
10/10/1996 |
K000314 |
ENGINEERED MEDICAL SYSTEMS |
INCENTIVE SPIROMETER |
04/12/2000 |
K080299 |
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH |
RESPIFIT S, MODEL RS-LR1001004 |
01/13/2009 |
K961077 |
HEALTHSCAN PRODUCTS, INC. |
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE |
07/15/1996 |
K974848 |
HOUGEN MFG., INC. |
MINI-CISER |
08/06/1998 |
K992256 |
INTERCONTINENTAL NEW TECHNOLOGIES, INC. |
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 |
01/11/2000 |
K053149 |
LEVENTON, S.A. |
SPIRO-BALL |
12/13/2005 |
K994074 |
LEVENTON, S.A. |
TRI-BALL |
06/08/2000 |
K221058 |
Lung Trainers, LLC |
LungTrainer (MD2 & MD3) |
07/05/2023 |
K163091 |
Medica Holdings, LLC |
VibraPEP |
02/21/2017 |
K153441 |
Medica Holdings, LLC |
VibraPEP |
03/25/2016 |
K091557 |
MEDICAL ACOUSTICS |
LUNG FLUTE THERAPEUTIC |
01/04/2010 |
K160837 |
MEDINET SRL |
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM |
02/23/2017 |
K220565 |
Medline Industries, Inc. |
Hudson RCI Triflo II Incentive Deep Breathing Exerciser |
10/25/2022 |
K954492 |
MERCURY MEDICAL |
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX |
10/21/1996 |
K972042 |
PARI HOLDING CO. |
PARI PEP THERAPY SYSTEM |
08/05/1997 |
K983308 |
PARI HOLDING CO. |
RC CORNET, MODEL #44F50 |
06/04/1999 |
K150044 |
PARI RESPIRATORY EQUIPMENT, INC. |
O-PEP |
05/27/2016 |
K090829 |
PARI RESPIRATORY EQUIPMENT, INC. |
PARI PEP S |
07/21/2009 |
K222018 |
PEEP Medical LLC dba GO2 Devices |
Breathe+ |
06/02/2023 |
K972824 |
PN MEDICAL |
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER |
04/03/1998 |
K203378 |
Respinova Ltd. |
Pulsehaler |
03/31/2021 |
K181660 |
Smiths Medical |
Acapella Choice Blue Vibratory PEP Device |
10/24/2019 |
K182847 |
Teleflex Medical, Inc |
Hudson RCI Voldyne Volumetric Exerciser |
07/01/2019 |
K953055 |
THE MERLIN CORP. |
MISTASSIST BREATHING EXERCISER |
02/08/1996 |
K150173 |
Trudell Medical International |
Aerobika OPEP Devive with Manometer |
10/15/2015 |
K183108 |
Trudell Medical International |
Combined Aerobika OPEP and VersaPAP device |
08/16/2019 |
K173918 |
Trudell Medical International |
VersaPAP Positive Airway Pressure (PAP) Device |
08/17/2018 |
K123400 |
TRUDELL MEDICAL INTL. |
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE |
05/16/2013 |
K012368 |
TRUDELL MEDICAL INTL. |
AEROPEP |
02/12/2002 |
K984468 |
VITAL SIGNS, INC. |
VITAL PEP |
06/01/1999 |