Cleared Traditional

K240373 - Air compression Leg Massager (MM0520, MM0521, MM0522) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240373 · Zhangzhou Easepal Medical Science and Technology Co., Ltd. · Physical Medicine device
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Sep 2024
Decision
223d
Days
Class 2
Risk

K240373 is an FDA 510(k) clearance for the Air compression Leg Massager (MM0520, MM0521, MM0522). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Zhangzhou Easepal Medical Science and Technology Co., Ltd. (Zhangzhou, CN). The FDA issued a Cleared decision on September 17, 2024 after a review of 223 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhangzhou Easepal Medical Science and Technology Co., Ltd. devices

Submission Details

510(k) Number K240373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2024
Decision Date September 17, 2024
Days to Decision 223 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 115d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Eva Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 149
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