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510(k) K252849

AffloVest® Mobile Airway Clearance Therapy by Tactile Medical — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2026
Date Received
September 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

Other clearances by Tactile Medical

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  • K173603 — Monarch Airway Clearance System (October 24, 2018)
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