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 ID00016958058420
NIH Device Record Key4be62b37-f5e0-491e-914a-93a73da7fc91
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwitch-It Head Controls-External
Version Model NumberHead Control
Catalog NumberSWI
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958058420 [Primary]

FDA Product Code

KNOAccessories, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-04
Device Publish Date2023-09-26

Devices Manufactured by SUNRISE MEDICAL (US) LLC

00016958059526 - Quickie2024-12-10 A lightweight folding wheelchair that provides mobility and portability for those Adults that weigh 140 kilograms (309 lbs.) or
00016958059366 - Empluse2024-08-01 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 GS2024-02-02 The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame whe
00016958057034 - Zippie X'Cape2024-02-02 The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a
00016958057041 - Quickie 5R2024-02-02 The Quickie® 5R is designed to deliver superior rigid wheelchair performance day after day. As you and your environment evolve,
00016958047349 - Zippie TS SE2023-11-22 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.