510(k) K253555
K253555 is an FDA 510(k) premarket notification submitted by Tactile Medical for the device "Flexitouch® Plus Advanced Pneumatic Compression System". The FDA issued a decision of Substantially Equivalent on Jul 31, 2026. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Tactile Medical has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2026
- Date Received
- Nov 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
- 510(k)