Cleared Traditional

K241433 - EVE Synergy (EVE-20M) (FDA 510(k) Clearance)

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

K241433 · Weero Co., Ltd. · Neurology device
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Jun 2025
Decision
379d
Days
Class 2
Risk

K241433 is an FDA 510(k) clearance for the EVE Synergy (EVE-20M). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Weero Co., Ltd. (Suwon, KR). The FDA issued a Cleared decision on June 4, 2025 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5850 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Weero Co., Ltd. devices

Submission Details

510(k) Number K241433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2024
Decision Date June 04, 2025
Days to Decision 379 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 148d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Neurology devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 544
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