510(k) K252849

Device
AffloVest® Mobile Airway Clearance Therapy
Applicant
Tactile Medical
510(k) number
K252849
Product code
BYI
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-30
Date received
2025-09-08
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
Sunday Hoy
Address
3701 Wayzata Blvd. Suite 300 Minneapolis MN US 55416 55416

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
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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