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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K252849
Device Name AffloVest® Mobile Airway Clearance Therapy
Applicant
Tactile Medical
3701 Wayzata Blvd.
Suite 300
Minneapolis,  MN  55416
Applicant Contact Sunday Hoy
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Jessica Buell
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/08/2025
Decision Date 04/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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