Cleared Traditional

K133483 - PORTABLE THERAPEUTIX SQUID ACTIVE COLD ...

K133483 is an FDA 510(k) clearance for PORTABLE THERAPEUTIX SQUID ACTIVE COLD ..., manufactured by Portable Therapeutix. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K133483 · Portable Therapeutix · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
118d
Days
Class 2
Risk

K133483 is an FDA 510(k) clearance for the PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR O.... Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Portable Therapeutix (Ashland, US). The FDA issued a Cleared decision on March 11, 2014 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Portable Therapeutix devices

FDA 510(k) Submission Details - K133483

510(k) Number K133483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2013
Decision Date March 11, 2014
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 101
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K133483.
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