Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)— 510(k) K250046
Substantially EquivalentShenzhen Urion Technology Co., Ltd.
FDA 510(k) clearance K250046 for Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617), Substantially Equivalent on 2025-04-25. Applicant: Shenzhen Urion Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Urion Technology Co., Ltd.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code IRP
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view all- K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
- K243115 — Upper 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))
- K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
- K200802 — Infrared Thermometer
Data sourced from openFDA. This site is unofficial and independent of the FDA.