510(k) K250860

Device
BreatheBand® (Model 1000)
Applicant
Exemplar Medical, LLC
510(k) number
K250860
Product code
BYI
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2025-03-21
Regulation
868.5665
Classification name
Percussor, Powered-Electric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Christian Moore
Address
4521 Wornall Rd. Suite 106 Kansas City MO US 64111 64111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252849AffloVest® Mobile Airway Clearance TherapyTactile Medical2026-04-30
K242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.2024-12-19
K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.2024-12-18
K233441The Vest APX System (PVAPX1)Baxter Healthcare Corportation2024-03-22
K222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.2022-11-18
K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.2021-02-12
K203209AirPhysio Positive Expiratory Pressure (PEP) DeviceAirphysio Pty, Ltd.2021-01-15
K173603Monarch Airway Clearance SystemHill-Rom Holdings, Inc.2018-10-24
K163378Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd.2017-03-17
K142482The Vest Airway Clearance SystemHill-Rom Services Private Limited2015-05-07
K132794SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.2013-12-19
K121587BREATH SHAKECheen Houng Ent. Co. , Ltd.2013-11-22
K122480INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation2013-03-27
K121170RESIN 11Respinnovation Sas2012-07-13
K103176FREQUENCERDymedso, Inc.2011-01-26