FDA.reportPublic FDA data

CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick

Primary DI
00016958058437
Brand
CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick
Company
SUNRISE MEDICAL (US) LLC
Model
Switch-It
Catalog number
SWI
Device description
"Alternative drive controls for users who cannot use standard power wheelchair controls. Update: CTRL+5, Dual Pro and the MicroGuide will no longer use this UDI number. MicoPilot is no longer in distribution. The ""Brand Name"" section of this form cannot be edited after the initial publishing. "
Published
2021-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00016958058437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016958058437000169580584370169580584370016958058437

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair steering/control unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962525056
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016958061888JAY LITEPRO CUSHIONJLPXXYY2026-03-05
00016958057591RGKOctane2023-09-05
00016958059373RGK Octane Sub4Sub 42023-09-05
00016958060249RGK Octane FXFX2023-09-05
00016958053593Quickie QX/QXiQX/QXiEIF62021-05-04
00016958053661Quickie SR45SR45EIZ92021-05-04
00016958056761Quickie XtenderQuickie XtenderEIXT2021-05-03
00016958058413Cool Cube / TouchDrive 2CCB / TD2SWI2021-05-12
00016958050110Jay EasyEasyE2607 / E26082023-09-12
00016958050127Jay Basic BackBasic Back2023-09-12
00016958050134Jay Focus Point BackFocus Point Back2023-09-12
00016958053135Jay Encompass BackEncompass2023-09-12
00016958053647Zippie VoyageVoyage; Voyage VIPEIZ14. EIZ16, EIZ182023-09-12
00016958056563Jay Fusion Jay Flow Fluid/Jay Air/ Jay Fluid w/CryoE2622/ E2623 / E2624 / E26252023-09-12
00016958058451Switch-It MicroGuide, MicroPilot, VersaGuide, VersaGuideEZ, SWI2023-09-12
00016958059694 Xtreme X8 4WDXtreme X8EIMM2023-09-12
00016958059380EmpluseF35EISP112025-04-21
00016958059526QuickieQS5 XEIF72024-12-02
00016958059366EmpluseR20EISP92024-07-24
00016958059465Empulse R90EISP82024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077026587EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-15
06972077026365EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026372EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026389EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026396EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026457EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026464EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026471EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026488EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026495EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026334EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026358EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082689077Spex SeatingSPEX LIMITEDKNN2026-04-30
09420082695511Spex SeatingSPEX LIMITEDKNN2026-04-30
06934726614484Battery ChargerLongfian Scitech Co., Ltd.KNN2026-04-25
10080196470723MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
10884389115954MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-16
40884389115788MEDLINEMEDLINE INDUSTRIES, INC.KNN2026-04-13
09420082699441Spex SeatingSPEX LIMITEDKNN2026-04-04
09420082699458Spex SeatingSPEX LIMITEDKNN2026-04-04
09420051799851Spex SeatingSPEX LIMITEDKNN2025-11-21
05407008321222mo-vismo-VisKNN2025-11-19
05407008321239mo-vismo-VisKNN2025-11-19
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051725195Spex LimitedSPEX LIMITEDKNN2025-11-07