FDA.reportPublic FDA data

Switch-It Vigo Head Drive Kit

Primary DI
05999862023003
Brand
Switch-It Vigo Head Drive Kit
Company
NowTechnologies Zrt.
Model
8018.02
Device description
The Switch-It Vigo Head Drive Kit is a proportional head drive solution / special input device for quadriplegic power wheelchair users.
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05999862023003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999862023003059998620230035999862023003

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
401643202
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540147003036MANUAL RECLINE ASSEMBLY WITH CROSSBRACEMotion Concepts IncKNN2026-07-06
07540147003043MANUAL RECLINE ASSEMBLY WITH CROSSBRACEMotion Concepts IncKNN2026-07-06
07540147003050Matrx MAC back Interface, Recline System UL MAXX & Adult StanderMotion Concepts IncKNN2026-07-03
07540147003067Matrx MAC back Interface, Tilt Only, UL & MINI MAXXMotion Concepts IncKNN2026-07-03
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
09420082689060Spex SeatingSPEX LIMITEDKNN2026-04-30
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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
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05407008321239mo-vismo-VisKNN2025-11-19
09420051706521Spex LimitedSPEX LIMITEDKNN2025-11-07
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09420051747746Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747852Spex LimitedSPEX LIMITEDKNN2025-11-07
09420051747869Spex LimitedSPEX LIMITEDKNN2025-11-07
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09420051770690Spex LimitedSPEX LIMITEDKNN2025-11-07