Cleared Traditional

EVE Synergy (EVE-20M)

K241433 · Weero Co., Ltd. · Neurology

Jun 2025

Decision

379d

Days

Class 2

Risk

About This 510(k) Submission

K241433 is an FDA 510(k) clearance for the EVE Synergy (EVE-20M), a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Weero Co., Ltd. (Suwon, KR). The FDA issued a Cleared decision on June 4, 2025, 379 days after receiving the submission on May 21, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K241433 FDA.gov
FDA Decision	Cleared 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