Cleared Traditional

K080134 - COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)

K080134 is an FDA 510(k) clearance for COMPRESSIBLE LIMB AND CIRCULATION THERA..., manufactured by Wonjin Mulsan Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K080134 · Wonjin Mulsan Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
371d
Days
Class 2
Risk

K080134 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Wonjin Mulsan Co., Ltd. (La Mirada, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Wonjin Mulsan Co., Ltd. devices

FDA 510(k) Submission Details - K080134

510(k) Number K080134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2008
Decision Date January 23, 2009
Days to Decision 371 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
255d slower than avg
Panel avg: 116d · This submission: 371d
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 139
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K080134.
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
K102319 · Won Industrial Co. · Jan 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
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
K071596 · Nihon Seimitsu Sokki Co., Ltd. · Feb 2008
GAME READY CLASSIC SYSTEM, MODEL 550550
K072620 · Coolsystems, Inc. · Oct 2007
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
K071050 · Coolsystems, Inc. · Jun 2007