Cleared Special

K100656 - COMPRESSIBLE LIMB THERAPY SYSTEM MODEL ...

K100656 is an FDA 510(k) clearance for COMPRESSIBLE LIMB THERAPY SYSTEM MODEL ..., manufactured by Wonjin Mulsan Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Special 510(k) pathway after a 79-day FDA review.

K100656 · Wonjin Mulsan Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
79d
Days
Class 2
Risk

K100656 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Wonjin Mulsan Co., Ltd. (Buena Park, US). The FDA issued a Cleared decision on May 26, 2010 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wonjin Mulsan Co., Ltd. devices

FDA 510(k) Submission Details - K100656

510(k) Number K100656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2010
Decision Date May 26, 2010
Days to Decision 79 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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

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