B.Body Evo 434300

GUDID 07640161460072

Bemer Int. AG

Hand-held deep-tissue electromagnetic stimulator

• Primary Device ID: 07640161460072
• NIH Device Record Key: 8608637e-be44-4e08-86e0-18e2fec6045b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.Body Evo
• Version Model Number: BEMER Therapy System Evo
• Catalog Number: 434300
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	07640161460072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231368

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by Bemer Int. AG

• 07640161460904 - BEMER Classic-Set Evo (B.Body): 2025-04-01
• 07640161460959 - BEMER Classic-Set Evo (B.Bed): 2025-04-01
• 07640161464100 - BEMER Basic-Set Evo: 2025-04-01
• 07640161464117 - BEMER Premium-Set Evo: 2025-04-01
• 07640161464124 - Beauty Pack Evo: 2025-04-01
• 07640161460065 - B.Pad Evo: 2025-03-13
• 07640161460072 - B.Body Evo: 2025-03-13
• 07640161460072 - B.Body Evo: 2025-03-13
• 07640161460089 - B.Bed Evo: 2025-03-13