Prism

Basic Information

• Brand Name: Prism
• Primary DI: 10850390007380
• Version / Model: Prism1
• Company Name: BTE TECHNOLOGIES, INC.
• Labeler DUNS: 021461470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-17
• Public Version: 1
• Public Version Date: 2022-06-27
• Public Version Status: New
• Public Device Record Key: 1c13d994-6ed1-4014-8b06-1fa79985283e

Device Description

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.

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
63457	Biomechanical function analysis system, force-testing, stationary	A stationary computerized device assembly designed for analysis of biomechanical/neuromuscular strength using dedicated hardware (e.g., dynamometers); the system may be designed for additional neuromuscular function testing (e.g., range of motion or pain/touch sensitivity). It includes a non-portable piece of primary hardware that allows for strength testing during a variety of movements (e.g., lifting, pulling), typically with a variety of dynamometer attachments (e.g., handles, bars, cables) and computer interface devices/computer with dedicated software. It is not intended for interactive gaming and is not based on tracking movement through space (i.e., not a kinesiology system).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850390007380	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