eMVFit

GUDID 08809851470053

Pain management device with RF, Vacuum and EMS

WEERO Co., Ltd.

Multi-modality physical therapy system

• Primary Device ID: 08809851470053
• NIH Device Record Key: 964bed3c-f246-4f0c-bf28-ede80fd3a6fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eMVFit
• Version Model Number: MVF-10M
• Company DUNS: 963224510
• Company Name: WEERO Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	08809851470053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240991

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2024-10-30
• Device Publish Date: 2024-10-22

Devices Manufactured by WEERO Co., Ltd.

• 08809851470053 - eMVFit: 2024-10-30Pain management device with RF, Vacuum and EMS
• 08809851470053 - eMVFit: 2024-10-30 Pain management device with RF, Vacuum and EMS
• 08809851470060 - EVE Ace of Face: 2024-07-22