DS6

Basic Information

• Brand Name: DS6
• Primary DI: 00850064651065
• Version / Model: DS6-UB
• Company Name: Foresite Healthcare, LLC
• Labeler DUNS: 095335981
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: f576c445-8a39-4c58-b6ac-8f5a5329dc88

Device Description

Depth Sensor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17929	Biomechanical function analysis system, motion-tracking	A mains electricity (AC-powered) device assembly designed to track and evaluate the movement of the human body or body segments for the purpose of obtaining graphical visualization and biomechanical analysis of the body (e.g., spinal or joint movements). The device can also be used to determine the extent of ataxia (failure of muscular coordination) and will typically be used in the study of sports/work/rehabilitation related mechanisms/tasks; it is not dedicated to gait analysis alone. It may include various components to achieve its purpose [e.g., markers, sensors, video cameras, image processors, and computers].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850064651065	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry; handle with care