510(k) K222496
- Device
- Electromed SmartVest Airway Clearance System
- Applicant
- Electromed, Inc.
- 510(k) number
- K222496
- Product code
- BYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-18
- Date received
- 2022-08-18
- Regulation
- 868.5665
- Classification name
- Percussor, Powered-electric
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gregory Spurlock
- Address
- 500 Sixth Ave. NW New Prague MN US 56071 56071
FDA Registration Numbers#
- 3007309299
- 3006666710
- 2183816
- 2029275
- 3011270181
- 3008008970
- 3006087789
- 3023272766
- 2134852
- 2022691
- 8030647
- 1832562
- 8044169
- 3011120183
- 1024404
- 3023531666
- 1643817
- 2026894
- 1649518
- 2032098
- 3004961434
- 3012307300
- 3004183730
- 3010009632
- 3008145987
- 3018783526
- 9610639
- 3003589956
- 3000126629
- 3035523355
- 8021995
- 1314417
- 3021235837
- 1937060
- 1526863
Source Documents#
Other 510(k) Records For Product Code BYI #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases