Evaluator EV2

GUDID 10850390007342

BTE TECHNOLOGIES, INC.

Biomechanical function analysis system, force-testing, portable

• Primary Device ID: 10850390007342
• NIH Device Record Key: bbc0a593-fd0b-4833-84ac-966aa98c26a8
• Commercial Distribution Discontinuation: 2020-05-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Evaluator EV2
• Version Model Number: EV2
• Company DUNS: 021461470
• Company Name: BTE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Customer Support Contacts

• Phone: 4108500333
• Email: customer_service@btetech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850390007342 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-08
• Device Publish Date: 2016-08-25

Devices Manufactured by BTE TECHNOLOGIES, INC.

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