PrimusRS

Basic Information

• Brand Name: PrimusRS
• Primary DI: 10850390007243
• Version / Model: PrimusRS
• 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: 6
• Public Version Date: 2020-05-13
• Public Version Status: Update
• Public Device Record Key: 57e55c32-d0e6-4815-9d76-b43de2aca601

Device Description

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.

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: No
• 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
ISD	Exerciser, Measuring	Physical Medicine	890.5360	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	10850390007243	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K933611	000

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