Evaluator

Basic Information

• Brand Name: Evaluator
• Primary DI: 10850390007335
• Version / Model: Evaluator
• Company Name: BTE TECHNOLOGIES, INC.
• Labeler DUNS: 021461470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 5
• Public Version Date: 2020-05-13
• Public Version Status: Update
• Public Device Record Key: 10d61b1b-f36f-474f-9339-b0a01b12f60c

Device Description

A portable measurement system for quantifying musculoskeletal strength and range of motion.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63456	Biomechanical function analysis system, force-testing, portable	A portable computerized device assembly with multiple force-sensing hardware designed for analysis of biomechanical/neuromuscular function by enabling performance of: 1) multiple functional strength tests using a variety of hardware (e.g., dynamometers, pinchmeters); or 2) strength testing with additional neuromuscular function testing (range of motion or pain/touch sensitivity) using additional hardware (e.g., goniometer, algometer). The system is typically designed so results can be displayed on an off-the-shelf computer/smartphone. It is not intended for interactive gaming and is not primarily based on analysing movement through motion sensing (i.e., not a kinesiology system).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850390007335	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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