Cool Cube / TouchDrive 2

Basic Information

• Brand Name: Cool Cube / TouchDrive 2
• Primary DI: 00016958058413
• Version / Model: CCB / TD2
• Catalog Number: SWI
• Company Name: SUNRISE MEDICAL (US) LLC
• Labeler DUNS: 962525056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-12
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 5c4cb579-1a6c-476a-ba28-dc442c1b6b41

Device Description

The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions. The Switch-It TouchDrive2 uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Manufacturing Date: Yes
• 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
KNN	Components, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30018	Wheelchair steering/control unit	An electronic device used by a wheelchair occupant or attendant to guide the wheelchair's movements and direction of travel. This device may be operated by the occupant's hand, mouth, or signals provided by other means, or by the attendant as required. This device will include the installation package.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00016958058413	GS1