510(k) K250046
K250046 is an FDA 510(k) premarket notification submitted by Shenzhen Urion Technology Co., Ltd. for the device "Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Shenzhen Urion Technology Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- January 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type