K250046
- 510(k) number
- K250046
- Device name
- Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
- Applicant
- Shenzhen Urion Technology Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-04-25
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250046.pdf
Official FDA record: K250046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.