BEAR™

GUDID 07350120790118

BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ is a smart microcurrent facial toning device.

Foreo AB

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07350120790118
• NIH Device Record Key: db1cd87e-b7d1-4950-afbc-9f70cf069eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAR™
• Version Model Number: MINT
• Company DUNS: 352394143
• Company Name: Foreo AB
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350120790118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200803

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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: 2022-06-03
• Device Publish Date: 2022-05-26

On-Brand Devices [BEAR™ ]

• 07350092139502: BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmet
• 07350120790118: BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmet