Bioness Integrated System (BITS) Bedside Configuration

Basic Information

• Brand Name: Bioness Integrated System (BITS) Bedside Configuration
• Primary DI: 00810188050021
• Version / Model: BIT-2124
• Company Name: Bioness Medical, Inc.
• Labeler DUNS: 119378513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-18
• Public Version: 1
• Public Version Date: 2025-07-28
• Public Version Status: New
• Public Device Record Key: 359b7f8a-f658-4fe7-ac11-eee1d1b1b85b

Device Description

Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" 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: 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
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	00810188050021	GS1
Previous	00815962020122	GS1

Customer Contacts

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