Cleared Traditional

K102319 - COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008

K102319 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 164-day FDA review.

K102319 · Won Industrial Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
164d
Days
Class 2
Risk

K102319 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Won Industrial Co. (Buena Park, US). The FDA issued a Cleared decision on January 28, 2011 after a review of 164 days - an extended review cycle.

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 - K102319

510(k) Number K102319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date January 28, 2011
Days to Decision 164 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
48d slower than avg
Panel avg: 116d · This submission: 164d
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 K102319.
NORMATEC MVP
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COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
K102320 · Daesung Maref Co., Ltd. · Mar 2011
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
K100656 · Wonjin Mulsan Co., Ltd. · May 2010
VERSEO AIR PRESSURE MASSAGER
K092435 · The American Export Group & International Services · Mar 2010
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
K080134 · Wonjin Mulsan Co., Ltd. · Jan 2009
K102319 · COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
Download PDF FDA Summary Won Industrial Co.