MCU Multi-Cervical Unit

GUDID 10850390007427

A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.

BTE TECHNOLOGIES, INC.

Neck mechanical weight exerciser

• Primary Device ID: 10850390007427
• NIH Device Record Key: 5925ab4b-1df1-4958-8b7f-9a928fa5fc71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCU Multi-Cervical Unit
• Version Model Number: MCU 2
• 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	10850390007427 [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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• 10850390007427 - MCU Multi-Cervical Unit: 2020-05-13A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.
• 10850390007427 - MCU Multi-Cervical Unit: 2020-05-13 A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength.
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