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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) 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. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K250046.
When did Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) receive FDA 510(k) clearance?
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250046.
Who is the listed applicant for Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)?
The FDA 510(k) record lists Shenzhen Urion Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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 records listing Shenzhen Urion Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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).)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))K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)K200802Infrared ThermometerK160019U80 Series Upper Arm Electronic Blood Pressure Monitor View all 7 devices →
Related Devices (Code: IRP)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260944ManaCold Compression SystemManamed, LLCK260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE SaúdeK254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.
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.