FDA 510(k) Applications for Medical Device Product Code "BWF"
(Spirometer, Therapeutic (Incentive))
| 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 |
| K233855 | Enchant Tek Co. Ltd. | AllPEP | 02/02/2024 |
| 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 |
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