BITS Motion Sensor

Basic Information

• Brand Name: BITS Motion Sensor
• Primary DI: 00815962020634
• Version / Model: BITS-3355
• 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: 21f14c18-be1e-4ad2-a53c-a5dfb0f9c180

Device Description

Bioness Integrated Therapy System Version 3.0 Motion Sensor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
ISD	Exerciser, measuring	Physical Medicine	890.5360	2
PTY	Computerized cognitive assessment aid, exempt	Neurology	882.1470	2
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	00815962020634	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit