K253555
- 510(k) number
- K253555
- Device name
- Flexitouch® Plus Advanced Pneumatic Compression System
- Applicant
- Tactile Medical MN · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2026-07-31
- Date received
- 2025-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253555.pdf
Official FDA record: K253555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.