Bemer Therapy System 431400

GUDID 07640161460218

Bemer Int. AG

Hand-held deep-tissue electromagnetic stimulator

• Primary Device ID: 07640161460218
• NIH Device Record Key: 44454dab-9046-4db5-8433-5094e4a23c24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bemer Therapy System
• Version Model Number: B.SIT
• Catalog Number: 431400
• Company DUNS: 448002860
• Company Name: Bemer Int. AG
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161460218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210174

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Bemer Therapy System]

• 07640161461086: B.BODY Professional
• 07640161460218: B.SIT