Percussor, Powered-Electric
FDA product code BYI · Class II (moderate risk) · 21 CFR 868.5665 · Anesthesiology
58510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Electromed, Inc. 5
- American Biosystems, Inc. 4
- Dymedso, Inc. 3
- Strom Corp. 3
- Hudson Oxygen Therapy Sales Co. 2
- Bradstreet Clinical Research Assoc., Inc. 2
- Advanced Respiratory 2
- Med Systems 2
- Cussionair Therapy Products, Inc. 2
- Dhd Medical Products Div. Diemolding Corp. 1
- Alpha Medical Systems 1
- Tactile Medical 1
- General Physiotherapy, Inc. 1
- Ballard Medical Products 1
- Salter Labs 1
- Micro Tek Engineering 1
- B & F Medical Products, Inc. 1
- Medical Equipment Development Co., Inc. 1
- Life Design Systems, Inc. 1
- Merced Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252849 | AffloVest® Mobile Airway Clearance TherapyBYI · Traditional | Tactile Medical | 04/30/2026SE |
| K250860 | BreatheBand® (Model 1000)BYI · Traditional | Exemplar Medical, LLC | 10/02/2025SE |
| K242063 | LibAirty Airway Clearance SystemBYI · Traditional | Synchrony Medical , Ltd. | 12/19/2024SE |
| K240959 | Respiratory Muscle TrainerBYI · Traditional | Chongqing Moffy Innovation Technology Co., Ltd. | 12/18/2024SE |
| K233441 | The Vest APX System (PVAPX1)BYI · Traditional | Baxter Healthcare Corportation | 03/22/2024SE |
| K222496 | Electromed SmartVest Airway Clearance SystemBYI · Special | Electromed, Inc. | 11/18/2022SE |
| K201490 | Electro Flo 6 Airway Clearance SystemBYI · Traditional | Med Systems, Inc. | 02/12/2021SE |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) DeviceBYI · Traditional | Airphysio Pty, Ltd. | 01/15/2021SE |
| K173603 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Holdings, Inc. | 10/24/2018SE |
| K163378 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Services Pte, Ltd. | 03/17/2017SE |
| K142482 | The Vest Airway Clearance SystemBYI · Traditional | Hill-Rom Services Private Limited | 05/07/2015SE |
| K132794 | Smartvest Airway Clearance SystemBYI · Special | Electromed, Inc. | 12/19/2013SE |
| K121587 | Breath ShakeBYI · Traditional | Cheen Houng Ent. Co. , Ltd. | 11/22/2013SE |
| K122480 | International Biophysics Corporation AfflovestBYI · Traditional | International Biophysics Corporation | 03/27/2013SE |
| K121170 | Resin 11BYI · Traditional | Respinnovation Sas | 07/13/2012SE |
| K103176 | FrequencerBYI · Traditional | Dymedso, Inc. | 01/26/2011SE |
| K100749 | Frequencer Model V2XBYI · Traditional | Dymedso, Inc. | 08/31/2010SE |
| K063645 | Frequencer, Model 1001BYI · Traditional | Dymedso, Inc. | 03/15/2007SE |
| K060439 | Lung FluteBYI · Traditional | Medical Acoustics, LLC | 06/22/2006SE |
| K053248 | Smartvest Airway Clearance System, Model TLBYI · Traditional | Electromed, Inc. | 12/01/2005SE |
| K051383 | The Incourage SystemBYI · Traditional | Respiratory Technologies, Incorporated | 06/17/2005SE |
| K040367 | Medpulse Respiratory Vest System, Model 2000EZBYI · Special | Electromed, Inc. | 04/07/2004SE |
| K031876 | Electro Flo Percussor, Model 5000BYI · Traditional | Med Systems | 11/21/2003SE |
| K024309 | The Vest Airway Clearance System, Model 104BYI · Traditional | Advanced Respiratory | 02/21/2003SE |
| K012928 | Abi Vest Airway Clearance SystemBYI · Traditional | Advanced Respiratory | 10/09/2001SE |
| K993629 | Abi Vest Airway Clearance SystemBYI · Traditional | American Biosystems, Inc. | 01/21/2000SE |
| K982889 | Medpulse Respiratory Vest System, Model 1000BYI · Traditional | Electromed, Inc. | 06/01/1999SE |
| K974849 | X-Air-CiserBYI · Traditional | Hougen Mfg., Inc. | 08/06/1998SE |
| K972859 | Flutter DBYI · Traditional | Bradstreet Clinical Research Assoc., Inc. | 06/05/1998SE |
| K965192 | Thairapy Vest SystemBYI · Traditional | American Biosystems, Inc. | 06/24/1997SE |
| K946083 | Flutter(R)BYI · Traditional | Bradstreet Clinical Research Assoc., Inc. | 03/13/1995SE |
| K931988 | 3P (Pulmonary Percussive Pack)BYI · Traditional | Delta Medical Manuf, Inc. | 10/28/1994SE |
| K936121 | Thairapy SystemBYI · Traditional | American Biosystems, Inc. | 08/02/1994SE |
| K940986 | Flutter(R)BYI · Traditional | Varioraw SA | 05/24/1994SE |
| K913014 | EMS PercussorBYI · Traditional | Engineered Medical Systems | 10/23/1991SE |
| K901026 | MJ Percussor(Tm)BYI · Traditional | Merced Medical, Inc. | 03/15/1990SE |
| K892862 | Flex-Cup PercussorBYI · Traditional | Life Design Systems, Inc. | 05/25/1989SE |
| K882604 | Pulmo-PattyBYI · Traditional | Tower Stopper, Inc. | 01/04/1989SE |
| K884098 | Thairapy(Tm) Bronchial Drainage System, Model 101BYI · Traditional | American Biosystems, Inc. | 12/16/1988SE |
| K883899 | Manual Percussor CupsBYI · Traditional | Medical Components, Inc. | 12/13/1988SE |
| K880597 | Thumper Model P-1000BYI · Traditional | Micro Tek Engineering | 03/29/1988SE |
| K863658 | Salter Labs 3000 Series PercussorsBYI · Traditional | Salter Labs | 10/06/1986SE |
| K860510 | Neonate PercussorBYI · Traditional | Ballard Medical Products | 02/20/1986SE |
| K855129 | Neocussor (Massager, Battery) PoweredBYI · Traditional | General Physiotherapy, Inc. | 01/23/1986SE |
| K853965 | Neoguard Chest PercussorBYI · Traditional | Cas Medical Systems, Inc. | 12/03/1985SE |
| K842608 | Infant Percussor PA-010BYI · Traditional | Alpha Medical Systems | 07/23/1984SE |
| K821265 | Pneumopulssor (PPS II)BYI · Traditional | Strom Corp. | 07/26/1982SE |
| K821570 | Pneumo Pulssor IIIBYI · Traditional | Strom Corp. | 06/03/1982SE |
| K813438 | Pneumo PulssorBYI · Traditional | Strom Corp. | 12/29/1981SE |
| K812803 | Infant Percussor #5534BYI · Traditional | Hudson Oxygen Therapy Sales Co. | 12/03/1981SE |
| K812151 | MJ Neonatal PercussorBYI · Traditional | Cussionair Therapy Products, Inc. | 08/25/1981SE |
| K812166 | PercussorBYI · Traditional | Dhd Medical Products Div. Diemolding Corp. | 08/18/1981SE |
| K802646 | Hand Percussor Cup #65210BYI · Traditional | B & F Medical Products, Inc. | 11/12/1980SE |
| K802399 | Model 2500 Pneumatic PercussorBYI · Traditional | Medical Equipment Development Co., Inc. | 10/23/1980SE |
| K801982 | The Mcshirley PercussorBYI · Traditional | Mcshirley Products, Inc. | 09/16/1980SE |
| K800713 | MJ PercussorBYI · Traditional | Cussionair Therapy Products, Inc. | 04/10/1980SE |
| K790675 | 5300 PercussorBYI · Traditional | Hudson Oxygen Therapy Sales Co. | 04/18/1979SE |
| K771876 | Argyle Peocussor SystemBYI · Traditional | Sherwood Medical Industries | 10/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1515-2021 Class II | Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the…The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-0192-2018 Class II | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth…Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable… | Hill-Rom Manufacturing, Inc. | 09/15/2017Terminated |
| Z-1006-2015 Class II | FLUTTER Percussor respiratory device, packaged one unit per clear plastic package.…Customer notification that the device may be difficult to open or close. | Aptalis Pharmatech Inc. | 11/13/2014Terminated |