Cleared Traditional

K120166 - COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM

K120166 is an FDA 510(k) clearance for COMPRESSIBLE LIMB AND CIRCULATION THERA..., manufactured by Won Industrial Co.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K120166 · Won Industrial Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
116d
Days
Class 2
Risk

K120166 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Won Industrial Co. (Los Angeles, US). The FDA issued a Cleared decision on May 14, 2012 after a review of 116 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 - K120166

510(k) Number K120166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2012
Decision Date May 14, 2012
Days to Decision 116 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 116d · This submission: 116d
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 153
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K120166.
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
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K112890 · NormaTec Industries, LP · Jan 2012
K120166 · COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
Download PDF FDA Summary Won Industrial Co.