Cleared Traditional

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

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
11d faster than avg
Panel avg: 116d · 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 138
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
Intermittent pressure compression system (Compression Pump PT1005A
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