Cleared Traditional

K260944 - ManaCold Compression System

K260944 is an FDA 510(k) clearance for ManaCold Compression System, manufactured by Manamed, LLC. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K260944 · Manamed, LLC · Physical Medicine device
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Aug 2026
Decision
142d
Days
Class 2
Risk

K260944 is an FDA 510(k) clearance for the ManaCold Compression System. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Manamed, LLC (Denton, US). The FDA issued a Cleared decision on August 12, 2026 after a review of 142 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.

FDA 510(k) Submission Details - K260944

510(k) Number K260944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2026
Decision Date August 12, 2026
Days to Decision 142 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 116d · This submission: 142d
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 157
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K260944.
Normatec Elite Heat (PRO26-SH)
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K260944 · ManaCold Compression System
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