Switch-It Head Controls-External SWI

GUDID 00016958058420

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.

SUNRISE MEDICAL (US) LLC

Wheelchair steering/control unit

• Primary Device ID: 00016958058420
• NIH Device Record Key: 4be62b37-f5e0-491e-914a-93a73da7fc91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Switch-It Head Controls-External
• Version Model Number: Head Control
• Catalog Number: SWI
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958058420 [Primary]

FDA Product Code

• KNO: Accessories, Wheelchair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-04
• Device Publish Date: 2023-09-26

Devices Manufactured by SUNRISE MEDICAL (US) LLC

• 00016958059366 - Empluse: 2024-08-01 The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over
• 00016958059465 - Empulse: 2024-07-04 The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual prop
• 00016958045918 - Zippie GS: 2024-02-02 The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame whe
• 00016958057034 - Zippie X'Cape: 2024-02-02 The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a
• 00016958057041 - Quickie 5R: 2024-02-02 The Quickie® 5R is designed to deliver superior rigid wheelchair performance day after day. As you and your environment evolve,
• 00016958047349 - Zippie TS SE: 2023-11-22 The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, bui
• 00016958060850 - Switch-it: 2023-11-22 The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggle
• 00016958047325 - Jay: 2023-11-20 JAY® Fit Seating simplifies the world of made-to-order seating by offering a "semi-personalized" solution. A great option for i