Product code BYI
- Device name
- Percussor, Powered-Electric
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5665
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026-04-30 |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025-10-02 |
| K242063 | LibAirty Airway Clearance System | Synchrony Medical , Ltd. | 2024-12-19 |
| K240959 | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-18 |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024-03-22 |
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022-11-18 |
| K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021-02-12 |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021-01-15 |
| K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018-10-24 |
| K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017-03-17 |
| K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015-05-07 |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | 2013-12-19 |
| K121587 | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | 2013-11-22 |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | International Biophysics Corporation | 2013-03-27 |
| K121170 | RESIN 11 | Respinnovation Sas | 2012-07-13 |
| K103176 | FREQUENCER | Dymedso, Inc. | 2011-01-26 |
| K100749 | FREQUENCER MODEL V2X | Dymedso, Inc. | 2010-08-31 |
| K063645 | FREQUENCER, MODEL 1001 | Dymedso, Inc. | 2007-03-15 |
| K060439 | LUNG FLUTE | Medical Acoustics, LLC | 2006-06-22 |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | 2005-12-01 |
| K051383 | THE INCOURAGE SYSTEM | Respiratory Technologies, Incorporated | 2005-06-17 |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | Electromed, Inc. | 2004-04-07 |
| K031876 | ELECTRO FLO PERCUSSOR, MODEL 5000 | Med Systems | 2003-11-21 |
| K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | Advanced Respiratory | 2003-02-21 |
| K012928 | ABI VEST AIRWAY CLEARANCE SYSTEM | Advanced Respiratory | 2001-10-09 |
| K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | American Biosystems, Inc. | 2000-01-21 |
| K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 | Electromed, Inc. | 1999-06-01 |
| K974849 | X-AIR-CISER | Hougen Mfg., Inc. | 1998-08-06 |
| K972859 | FLUTTER D | Bradstreet Clinical Research Assoc., Inc. | 1998-06-05 |
| K965192 | THAIRAPY VEST SYSTEM | American Biosystems, Inc. | 1997-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816305024906 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305024913 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305024920 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305024937 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025101 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025248 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025255 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025262 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025279 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305025286 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 00816305024890 | AffloVest | Tactile Systems Technology, Inc. | 2026-05-27 |
| 10889483563113 | BALLARD™ | SUNMED, LLC | 2025-12-01 |
| 00609038968674 | Ballard* Manual Percussor | Avanos Medical, Inc. | 2020-06-20 |
| 00606959044128 | CoughAssist | Respironics, Inc. | 2019-03-04 |
| 00709078002410 | VIBRALUNG® | WESTMED, INC. | 2017-10-19 |
| 00746980002008 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-05-11 |
| 00746980001995 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-05-11 |
| 00746980001988 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-05-11 |
| 00746980001919 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-05-01 |
| 00746980001391 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-04-26 |
| 00746980001162 | G5® | GENERAL PHYSIOTHERAPY INC | 2017-04-25 |
| 00709078001529 | Vibralung Mask Interface Kit-Adult with Aerosol Delivery System | WESTMED, INC. | 2016-12-15 |
| 00709078001543 | Vibralung Mask Interface Kit-Pediatric w/Aerosol Delivery System | WESTMED, INC. | 2016-12-15 |
| 00709078001505 | Vibralung Patient Kit with Circulair II Model 0295 | WESTMED, INC. | 2016-12-15 |
| 00709078001352 | Vibralung Patient Kit | WESTMED, INC. | 2016-12-15 |
| 10788942540453 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942540330 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942540903 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942540606 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 00383480000068 | QUAKE | THAYER MEDICAL CORPORATION | 2016-09-21 |