KEEOGO - CLINICIAN KIT

GUDID 07540162060007

Powered walking assistance device

B-Temia Inc

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• Primary Device ID: 07540162060007
• NIH Device Record Key: dbff76ef-30b4-43de-b064-8aa12f265086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KEEOGO - CLINICIAN KIT
• Version Model Number: 5062601
• Company DUNS: 244220856
• Company Name: B-Temia Inc
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com
• Phone: 1 866 443-1010
• Email: info@b-temia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540162060007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201539

FDA Product Code

• PHL: Powered Exoskeleton

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: 2021-06-24
• Device Publish Date: 2021-06-16