FDA.reportPublic FDA data

RGK Octane FX

Primary DI
50567627060244
Brand
RGK Octane FX
Company
RGK WHEELCHAIRS LIMITED
Model
FX
Device description
The RGK Octane FX is a made-to-measure chair unlike any other. Imagine a wheelchair that folds down so small you can store it in most airplane overhead luggage compartments. Imagine a wheelchair that is as lightweight and performance-oriented as a rigid sports chair.
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
50567627060244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5056762706024450567627060244

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
50567627059378RGK Octane Sub4Sub42024-02-05

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