Air compression Leg Massager (MM0520, MM0521, MM0522)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240373

by Zhangzhou Easepal Medical Science And Technology Co., Ltd.

Identifiers

510(k) Number: K240373 FDA 510(k)
FDA Product Code: IRP FDA 510(k)
Models / Variants: MM0520 FDA 510(k)
MM0521 FDA 510(k)
MM0522 FDA 510(k)

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 device is a powered inflatable tube massager classified under product code IRP and regulation number 890.5650. It is a Class 2 medical device in the Physical Medicine specialty, substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

It was cleared via the Traditional 510(k) pathway under number K240373 on September 17, 2024, following a 223-day review. The device is manufactured by Zhangzhou Easepal Medical Science and Technology Co., Ltd. and is intended for use in physical medicine applications.

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: Air compression Leg Massager (MM0520, MM0521, MM0522) (K240373) — FDA ..., K240373 FDA 510(k) - Air compression Leg Massager (MM0520, Air compression Leg Massager (MM0520, MM0521, MM0522)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K240373	Class II	Active

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Manufacturer

Manufacturer: Zhangzhou Easepal Medical Science And Technology Co., Ltd.

Sources (1)

FDA 510(k) K240373 24 fields · synced Oct 6, 2026