Cleared Traditional

K250046 - Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (FDA 510(k) Clearance)

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

K250046 · Shenzhen Urion Technology Co., Ltd. · Physical Medicine device

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Apr 2025

Decision

105d

Days

Class 2

Risk

K250046 is an FDA 510(k) clearance for the Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, .... Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Shenzhen Urion Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 25, 2025 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Shenzhen Urion Technology Co., Ltd. devices

Submission Details

510(k) Number	K250046 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 10, 2025
Decision Date	April 25, 2025
Days to Decision	105 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

10d faster than avg

Panel avg: 115d · This submission: 105d

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.