Bioness Integrated Therapy System, BITS 3.0, BITS Balance

Basic Information

• Brand Name: Bioness Integrated Therapy System, BITS 3.0, BITS Balance
• Primary DI: 00815962020627
• Version / Model: BITS-3155
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-10
• Public Version: 1
• Public Version Date: 2020-08-18
• Public Version Status: New
• Public Device Record Key: 4571625c-b9d4-41db-ac55-8aeaada2c0c1

Device Description

BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
PTY	Computerized cognitive assessment aid, exempt	Neurology	882.1470	2
ISD	Exerciser, measuring	Physical Medicine	890.5360	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	00815962020627	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 176 Degrees Fahrenheit