510(k) K170216
K170216 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 May 26, 2017. The device falls under product code JOW (Sleeve, Limb, 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
- May 26, 2017
- Date Received
- January 24, 2017
- 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