Cleared Traditional

K130385 - COMPRESSIBLE LIMB SLEEVE SYSTEM (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130385 · Maxstar Industrial Co., Ltd. · Physical Medicine device
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Feb 2014
Decision
368d
Days
Class 2
Risk

K130385 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB SLEEVE SYSTEM. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Maxstar Industrial Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 18, 2014 after a review of 368 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 Maxstar Industrial Co., Ltd. devices

Submission Details

510(k) Number K130385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2013
Decision Date February 18, 2014
Days to Decision 368 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 115d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 149
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