BYI · Percussor, Powered-Electric
Anesthesiology · 21 CFR 868.5665 · Class 2
Overview
| Product Code | BYI |
|---|---|
| Device Name | Percussor, Powered-Electric |
| Regulation | 21 CFR 868.5665 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | Oct 2, 2025 | SESE |
| K242063 | LibAirty Airway Clearance System | Synchrony Medical , Ltd. | Dec 19, 2024 | SESE |
| K240959 | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | Dec 18, 2024 | SESE |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | Mar 22, 2024 | SESE |
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | Nov 18, 2022 | SESE |
| K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | Feb 12, 2021 | SESE |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | Jan 15, 2021 | SESE |
| K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | Oct 24, 2018 | SESE |
| K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | Mar 17, 2017 | SESE |
| K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | May 7, 2015 | SESE |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | Dec 19, 2013 | SESE |
| K121587 | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | Nov 22, 2013 | SESE |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | International Biophysics Corporation | Mar 27, 2013 | SESE |
| K121170 | RESIN 11 | Respinnovation Sas | Jul 13, 2012 | SESE |
| K103176 | FREQUENCER | Dymedso, Inc. | Jan 26, 2011 | SESE |
| K100749 | FREQUENCER MODEL V2X | Dymedso, Inc. | Aug 31, 2010 | SESE |
| K063645 | FREQUENCER, MODEL 1001 | Dymedso, Inc. | Mar 15, 2007 | SESE |
| K060439 | LUNG FLUTE | Medical Acoustics, LLC | Jun 22, 2006 | SESE |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | Dec 1, 2005 | SESE |
| K051383 | THE INCOURAGE SYSTEM | Respiratory Technologies, Incorporated | Jun 17, 2005 | SESE |
Top Applicants
- Electromed, Inc. — 5 clearances
- American Biosystems, Inc. — 4 clearances
- Dymedso, Inc. — 3 clearances
- Strom Corp. — 3 clearances
- Advanced Respiratory — 2 clearances
