FDA.reportPublic FDA data

RGK Octane Sub4

Primary DI
50567627059378
Brand
RGK Octane Sub4
Company
RGK WHEELCHAIRS LIMITED
Model
Sub4
Device description
The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about.
Published
2024-02-05
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
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200135000RGK Daily Range WheelchairsRgk Wheelchairs, Ltd.2020-09-10IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50567627059378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5056762705937850567627059378

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216729066
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50567627057596RGK OctaneOctane2024-02-05
50567627060244RGK Octane FXFX2024-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05907467831916REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831923REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831930REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831947REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831954REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831961REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831978REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831985REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831992REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832005REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832012REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832029REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832036REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832043REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832050REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832067REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832074REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832081REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832098REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832104REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832111REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832128REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832135REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836249REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836256REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836263REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836270REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853758REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853765REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853772REHASENSEREHASENSE SP Z O OIOR2026-10-30