ER

GUDID 10850390007311

BTE TECHNOLOGIES, INC.

Biomechanical function analysis system, force-testing, stationary

• Primary Device ID: 10850390007311
• NIH Device Record Key: 2735e69b-e002-4bea-86c2-88790f0308f2
• Commercial Distribution Discontinuation: 2019-12-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ER
• Version Model Number: ER
• 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	10850390007311 [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: 2020-03-04
• Device Publish Date: 2016-08-25

Devices Manufactured by BTE TECHNOLOGIES, INC.

• 10850390007380 - Prism: 2022-06-27 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne
• 10850390007373 - Evaluator: 2020-05-26 A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available th
• 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.
• 10850390007816 - Eccentron: 2020-05-13 A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measu
• 10850390007236 - Primus: 2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of
• 10850390007243 - PrimusRS: 2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of
• 10850390007328 - EvalTech: 2020-05-13 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne
• 10850390007335 - Evaluator: 2020-05-13 A portable measurement system for quantifying musculoskeletal strength and range of motion.