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

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

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
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31