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

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250046

Identifiers

510(k) Number: K250046 FDA 510(k)
FDA Product Code: IRP FDA 510(k)
Models / Variants: UM605 FDA 510(k)EUDAMED
UM606 FDA 510(k)EUDAMED
UM607 FDA 510(k)EUDAMED
UM608 FDA 510(k)EUDAMED
UM609 FDA 510(k)EUDAMED
UM610 FDA 510(k)EUDAMED
UM611 FDA 510(k)EUDAMED
UM617 FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.5650 FDA 510(k)
Regulation Number: 890.5650 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Air Compression Leg Massager (UM605, UM606, UM607, UM608, UM609, UM610, UM611, UM617) is a Powered Inflatable Tube Massager designed for physical medicine applications. It employs air compression technology to provide therapeutic massage to the legs, intended to relieve muscle tension, improve circulation, and promote relaxation.

This device is supplied as a reusable, non-sterile medical instrument and is classified under FDA regulation 21 CFR 890.5650 as Class II. It operates in home or clinical settings and requires proper storage to maintain functionality. The device holds FDA 510(k) clearance and MDD authorization, ensuring compliance with regulatory standards for powered inflatable tube massagers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Shenzhen Urion Technology Co., Ltd. Janice Ou Official Applicant ..., Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610 ..., Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610 ..., PDF Shenzhen Urion Technology Co., Ltd. Janice Ou Official Applicant ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K250046	Class II	Active

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Manufacturer

Manufacturer: Shenzhen Urion Technology Co., Ltd.

Sources (2)

FDA 510(k) K250046 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026