FDA.reportPublic FDA data

Cool Cube / TouchDrive 2

Primary DI
00016958058413
Brand
Cool Cube / TouchDrive 2
Company
SUNRISE MEDICAL (US) LLC
Model
CCB / TD2
Catalog number
SWI
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 (currently not in distribution) uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control.
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
00016958058413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00016958058413000169580584130169580584130016958058413

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
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
00016958058437CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStickSwitch-ItSWI2021-05-12
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