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

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Apr 25, 2025 after 105 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K850316 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222991: Air Compression Leg Massager (model: EMK-701), Xiamen Emoka Health Science & Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
The Air Compression Leg Massager is used to temporarily relieve mild muscle pains and discomfort, and temporarily increase blood circulation to the treatment areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K250046
Methodology: https://510kreport.com/methodology