Simulator II

GUDID 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.

BTE TECHNOLOGIES, INC.

Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 10850390007151
• NIH Device Record Key: 4116c815-d37e-49ff-bf95-4970b1503387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simulator II
• Version Model Number: Sim II 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850390007151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800007

FDA Product Code

• BXB: Exerciser, Powered

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: 2020-05-08
• Device Publish Date: 2016-08-25

On-Brand Devices [Simulator II]

• 10850390007151: A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offer
• 10850390007137: A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offer