BEAR 2

GUDID 07350120791795

Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.

Foreo AB

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07350120791795
• NIH Device Record Key: 2c7ebd7a-8290-4d13-9c23-f8ad7cd36668
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAR 2
• Version Model Number: Fuchsia
• 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350120791795 [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: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [BEAR 2]

• 07350120791818: Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmet
• 07350120791801: Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmet
• 07350120791795: Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmet