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WEERO Co., Ltd.

Matched from indexed company URL: Weero Co.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30160876533016087653WEERO Co., Ltd.1N2026-01-01A-205, Venture Valley II, 142-10, Saneop-ro 156 beon-gil, Gwonse Suwon-si,Gyeonggi-do KR 16648

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3069081917709462K253261Apollo Quattro (APQ-10M)PBX2026-03-13
3069081149029372K241433EVE Synergy (EVE-20M)IPF2025-06-04
3069081838050364K240992eMVFit (MVF-10M)IPF2024-10-10
3069081784649885K240991eMVFit (MVF-10M)PBX2024-10-09
3069081094340038K212253Apollo Duet (Model : APD-4000)PBX2022-08-25
3069081145026554

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PBX32026-03-13
IPF22025-06-04

PMN#

GUDID#

EVE Synergy; EVE Titan - 1) EVE Synergy is also marketed under the brand name 'EVE Titan' with an updated logo design.2) This device provides pain relief through RF (Radio Frequency), EMS (Electrical Muscle Stimulation), and TENS (Transcutaneous Electrical Nerve Stimulation) technologies.It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

WEERO Co., Ltd.

2025-06-24