Cleared Traditional

K131193 - ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131193 · Tactile Systems Technology, Inc. · Cardiovascular device
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Jun 2013
Decision
53d
Days
Class 2
Risk

K131193 is an FDA 510(k) clearance for the ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Tactile Systems Technology, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 18, 2013 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tactile Systems Technology, Inc. devices

Submission Details

510(k) Number K131193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2013
Decision Date June 18, 2013
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K131193.
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