Cleared Traditional

K241433 - EVE Synergy (EVE-20M)

K241433 is an FDA 510(k) clearance for EVE Synergy (EVE-20M), manufactured by Weero Co., Ltd.. The device is a Class 2 Neurology device with product code IPF cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K241433 · Weero Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K241433

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.

IPF Device Classification - Class 2, Special Controls

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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K241433.
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