EVE Synergy (EVE-20M)— 510(k) K241433

Substantially Equivalent

Weero Co., Ltd.

FDA 510(k) clearance K241433 for EVE Synergy (EVE-20M), Substantially Equivalent on 2025-06-04. Applicant: Weero Co., Ltd.. Device class: 2.

Clearance details

Applicant: Weero Co., Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-05-21
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

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K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241488 — TrainFES Advance2025-02-05

More clearances from Weero Co., Ltd.

K253261 — Apollo Quattro (APQ-10M)2026-03-13
K240992 — eMVFit (MVF-10M)2024-10-10
K240991 — eMVFit (MVF-10M)2024-10-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.