Class Class II

Air Compression Leg Massager (model: EMK-701) (K222991)

K222991 2023-03-15 Traditional
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Description

Air Compression Leg Massager (model: EMK-701) by Xiamen Emoka Health Science & Technology Co., Ltd., an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222991
Clearance Date2023-03-15
Clearance TypeTraditional
Product CodeIRP
Regulation Number890.5650

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Predicate lineage for K222991

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 (model: EMK-701) (K222991) cites 2 predicate devices and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K212935Air Pressure Foot MassagerXiamen Simo Electronic Co., Ltd.2022
K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co....2020

Later devices that cite this one as their predicate

Devices that cite K222991
K numberDeviceApplicantYear
K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM...Shenzhen Urion Technology Co., Ltd.2025
K242140Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co...2025

Trace the full predicate network for K222991

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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