Kinetigram

Basic Information

• Brand Name: Kinetigram
• Primary DI: 00860007286506
• Version / Model: v2
• Catalog Number: 200-00201-DO-01
• Company Name: Bioniks
• Labeler DUNS: 078436734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-29
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 916d3794-342c-489a-8542-103a3902fd19

Device Description

Kinetigram is a cloud-based software platform that provides upper mobility assessment

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
KQX	Goniometer, Ac-Powered	Orthopedic	888.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47518	Biomechanical function analysis/rehabilitation software	A software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing and/or enable viewing of patient performance data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007286506	GS1

Customer Contacts

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