K153311 is an FDA 510(k) clearance for the Flexitouch System. This device is classified as a Sleeve, Head And Neck, Compressible (Class II - Special Controls, product code PPS).
Submitted by Tactile Systems Technology, Inc. (Dba Tactile Medical) (Minneapolis, US). The FDA issued a Cleared decision on September 14, 2016, 302 days after receiving the submission on November 17, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800. Intended To Move Excess Fluid From The Target Area To Another Area Of The Body..
| 510(k) Number | K153311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2015 |
| Decision Date | September 14, 2016 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PPS - Sleeve, Head And Neck, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |
| Definition | Intended To Move Excess Fluid From The Target Area To Another Area Of The Body. |