Cleared Special

Air Relax (K173158) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173158 · Maxstar Industrial Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
608d
Days
Class 2
Risk

K173158 is an FDA 510(k) clearance for the Air Relax. 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 May 30, 2019 after a review of 608 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 K173158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date May 30, 2019
Days to Decision 608 days
Submission Type Special
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
493d slower than avg
Panel avg: 115d · This submission: 608d
Pathway characteristics
Modification to existing cleared device.

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

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