Bioness Integrated System (BITS)2.0.5

Basic Information

• Brand Name: Bioness Integrated System (BITS)2.0.5
• Primary DI: 00815962020221
• Version / Model: BIT-2055
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b99e4dd8-c09e-4c36-84af-c4cde29c69e8

Device Description

Bioness Integrated Therapy System, Version 2.0, 55" Display with Software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
30908	Perceptual-coordination assistive training device	A device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962020221	GS1

Customer Contacts

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