Eccentron

GUDID 10850390007816

A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface.

BTE TECHNOLOGIES, INC.

Bicycle ergometer Bicycle ergometer

• Primary Device ID: 10850390007816
• NIH Device Record Key: b5370b0d-e85b-46bd-a231-792c268ba352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eccentron
• Version Model Number: LE1
• 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: 410-850-0333
• Email: Customer_Service@btetechnologies.com
• Phone: 410-850-0333
• Email: Customer_Service@btetechnologies.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 55 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 55 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850390007816 [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: 2020-05-13
• Device Publish Date: 2016-08-25

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