Class Class II

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (K250046)

K250046 2025-04-25 Traditional
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Description

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) by Shenzhen Urion Technology Co., Ltd., an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250046
Clearance Date2025-04-25
Clearance TypeTraditional
Product CodeIRP
Regulation Number890.5650

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Predicate lineage for K250046

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (K250046) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K222991Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Techn...2023

Trace the full predicate network for K250046

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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