K252849
- 510(k) number
- K252849
- Device name
- AffloVest® Mobile Airway Clearance Therapy
- Applicant
- Tactile Medical MN · US
- Product code
- BYI — Percussor, Powered-Electric
- Decision date
- 2026-04-30
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252849.pdf
Official FDA record: K252849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.