Flexitouch® Plus Advanced Pneumatic Compression System— 510(k) K253555
Substantially EquivalentTactile Medical
FDA 510(k) clearance K253555 for Flexitouch® Plus Advanced Pneumatic Compression System, Substantially Equivalent on 2026-07-31. Applicant: Tactile Medical. Device class: 2.
Summary
Tactile Medical's Flexitouch Plus Advanced Pneumatic Compression System is filed under JOW, compressible limb sleeves. The record doesn't list components or models.
Class II, 21 CFR 870.5800. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tactile Medical filed from Minneapolis, Minnesota. The decision came 259 calendar days after FDA received it (November 14, 2025 to July 31, 2026).
Clearance details
- Applicant
- Tactile Medical
- Product code
- Product code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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