Air compression Leg Massager (MM0520, MM0521, MM0522)

FDA 510(k) K240373 · Zhangzhou Easepal Medical Science and Technology Co., Ltd.

Substantially Equivalent

510(k) numberK240373

Submission

Device name
Air compression Leg Massager (MM0520, MM0521, MM0522)
Applicant
Zhangzhou Easepal Medical Science and Technology Co., Ltd.
Zhangzhou, CN
Received
February 7, 2024
Decision date
September 17, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IRP – Massager, Powered Inflatable Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5650
Specialty
Physical Medicine

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Questions and answers

When was Air compression Leg Massager (MM0520, MM0521, MM0522) cleared by the FDA?

Air compression Leg Massager (MM0520, MM0521, MM0522) (K240373) received a 510(k) decision of Substantially Equivalent on September 17, 2024, 223 days after the submission was received.

What is the product code of K240373?

The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.