Cleared Traditional

K250046 - Air Compression Leg Massager (UM605

K250046 is an FDA 510(k) clearance for Air Compression Leg Massager (UM605, manufactured by Shenzhen Urion Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K250046 · Shenzhen Urion Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K250046

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.

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

All 98
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K250046.
Compression Therapy Device (LGT-2210DS)
K250244 · Guangzhou Longest Medical Technology Co., Ltd. · Jul 2025
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K242615 · Xiamen Taotao Technology Co., Ltd. · Jul 2025
ZT Clinic (MG675A)
K242754 · Zamar Medical D.O.O. · May 2025
Air Compression Leg Massager (K-705)
K242140 · Jiale Health Technology Shenzhen Co., Ltd. · Mar 2025
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
K243206 · Sichuan Qianli-Beoka Medical Technology, Inc. · Feb 2025
Game Ready system (550500-04)
K243572 · Avanos Medical, Inc. · Jan 2025