AffloVest® Mobile Airway Clearance Therapy
K-Number: K252849 · 2026-04-30
ApplicantTactile Medical
Decision Date2026-04-30
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AffloVest® Mobile Airway Clearance Therapy is a medical device manufactured by Tactile Medical. It received FDA 510(k) clearance on 2026-04-30 under approval number K252849. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AffloVest® Mobile Airway Clearance Therapy?
AffloVest® Mobile Airway Clearance Therapy is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Tactile Medical. The 510(k) number is K252849.
When was AffloVest® Mobile Airway Clearance Therapy approved by the FDA?
AffloVest® Mobile Airway Clearance Therapy received FDA 510(k) clearance on 2026-04-30, under approval number K252849.
What company makes AffloVest® Mobile Airway Clearance Therapy?
AffloVest® Mobile Airway Clearance Therapy is manufactured by Tactile Medical.
What is the FDA product code for AffloVest® Mobile Airway Clearance Therapy?
The FDA product code for AffloVest® Mobile Airway Clearance Therapy is BYI.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.