Cleared Traditional

K191441 - Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) (FDA 510(k) Clearance)

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

K191441 · Maxstar Industrial Co., Ltd. · Physical Medicine device
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Mar 2021
Decision
645d
Days
Class 2
Risk

K191441 is an FDA 510(k) clearance for the Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Maxstar Industrial Co., Ltd. (Gimpo, KR). The FDA issued a Cleared decision on March 5, 2021 after a review of 645 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Maxstar Industrial Co., Ltd. devices

Submission Details

510(k) Number K191441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date March 05, 2021
Days to Decision 645 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
530d slower than avg
Panel avg: 115d · This submission: 645d
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 Consultant

Med.Com
Chris Park

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 149
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