Switch-It Head Controls-External

Basic Information

• Brand Name: Switch-It Head Controls-External
• Primary DI: 00016958058420
• Version / Model: Head Control
• 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: 2023-09-26
• Public Version: 1
• Public Version Date: 2023-10-04
• Public Version Status: New
• Public Device Record Key: 4be62b37-f5e0-491e-914a-93a73da7fc91

Device Description

Switch-It traditional switched head arrays use zero-touch proximity sensors which are specifically designed for power wheelchair application and are less susceptible to interference from high electromagnetic fields generated by power wheelchairs.

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: Yes
• 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: 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
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	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	00016958058420	GS1