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FDA 510(k)

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

K-Number: K250046 · 2025-04-25

ApplicantShenzhen Urion Technology Co., Ltd.
Decision Date2025-04-25
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) is a medical device manufactured by Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under approval number K250046. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)?

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K250046.

When was Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) approved by the FDA?

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) received FDA 510(k) clearance on 2025-04-25, under approval number K250046.

What company makes Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)?

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) is manufactured by Shenzhen Urion Technology Co., Ltd..

What is the FDA product code for Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)?

The FDA product code for Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) is IRP.

Other Devices by Shenzhen Urion Technology Co., Ltd.

K160019U80 Series Upper Arm Electronic Blood Pressure Monitor K200802Infrared Thermometer K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

View all 7 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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