510(k) K153311
K153311 is an FDA 510(k) premarket notification submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) for the device "Flexitouch System". The FDA issued a decision of Substantially Equivalent on September 14, 2016. The device falls under product code PPS (Sleeve, Head And Neck, Compressible), a Class II device regulated under 21 CFR 870.5800. Tactile Systems Technology, Inc. (Dba Tactile Medical) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2016
- Date Received
- November 17, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Head And Neck, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
Intended to move excess fluid from the target area to another area of the body.