EVE Synergy; EVE Titan

GUDID 08809851470091

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.

Multi-modality physical therapy system, professional-use

• Primary Device ID: 08809851470091
• NIH Device Record Key: 3e9284c3-2d92-4a2e-b6dc-4914eafb7a64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVE Synergy; EVE Titan
• Version Model Number: EVE-20M
• Company DUNS: 963224510
• Company Name: WEERO Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809851470091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241433

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-24

Devices Manufactured by WEERO Co., Ltd.

• 08809851470091 - EVE Synergy; EVE Titan: 2025-06-241) 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.
• 08809851470091 - EVE Synergy; EVE Titan: 2025-06-24 1) EVE Synergy is also marketed under the brand name 'EVE Titan' with an updated logo design. 2) This device provides pain reli
• 08809851470053 - eMVFit: 2024-10-30 Pain management device with RF, Vacuum and EMS
• 08809851470060 - EVE Ace of Face: 2024-07-22