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FDA 510(k)

EVE Synergy (EVE-20M)

K-Number: K241433 · 2025-06-04

ApplicantWeero Co., Ltd.
Decision Date2025-06-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EVE Synergy (EVE-20M) is the device name listed in this FDA 510(k) record. The listed applicant is Weero Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K241433. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVE Synergy (EVE-20M)?

EVE Synergy (EVE-20M) is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Weero Co., Ltd.. The 510(k) number is K241433.

When did EVE Synergy (EVE-20M) receive FDA 510(k) clearance?

EVE Synergy (EVE-20M) received FDA 510(k) clearance on 2025-06-04, under 510(k) number K241433.

Who is the listed applicant for EVE Synergy (EVE-20M)?

The FDA 510(k) record lists Weero Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVE Synergy (EVE-20M)?

The FDA product code for EVE Synergy (EVE-20M) is IPF.

Other records listing Weero Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)K253261Apollo Quattro (APQ-10M)K240992eMVFit (MVF-10M)K240991eMVFit (MVF-10M)K212253Apollo Duet (Model : APD-4000)

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241488TrainFES AdvanceTrainfesK240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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