Clearance Summary
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM received FDA 510(k) clearance under submission number K131193, sponsored by Tactile Systems Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-06-18.
- Submission: K131193
- Applicant / Sponsor: Tactile Systems Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2013-06-18
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.