PrimusRS

GUDID 10850390007243

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.

BTE TECHNOLOGIES, INC.

Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 10850390007243
• NIH Device Record Key: 57e55c32-d0e6-4815-9d76-b43de2aca601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrimusRS
• Version Model Number: PrimusRS
• Company DUNS: 021461470
• Company Name: BTE TECHNOLOGIES, 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: 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	10850390007243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933611

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-13
• Device Publish Date: 2016-08-25

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