FDA.reportPublic FDA data

FOLD & GO Wheelchairs

Primary DI
G450MAGSHOCK00
Brand
FOLD & GO Wheelchairs
Company
Onekubed Designs LLC
Model
MagSHOCK®
Catalog number
MAG-SHOCK
Device description
WeatherPROOF Magnesium Frame Electric Wheelchairs, Weight Capacity up to 400 lbs, Hill Climb up to 25 degrees, FAA/TSA Fly Ready. Built for Any Type of Terrain Driving Conditions, and Backed by Our 3-Year Warranty.
Published
2025-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170787000Powered Wheelchair DYW30A(D09)Nanjing Jin Bai HE Medical Apparatus Co., Ltd.2017-08-09ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G450MAGSHOCK00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-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 using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099823918
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G450ARK5500FOLD & GO WheelchairsArk550®2026-02-27
G450NEUDOL0FOLD & GO WheelchairsNeudol®NEUDOL2025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351364BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29