FDA.reportPublic FDA data

Magic XT4

Primary DI
09356399060967
Brand
Magic XT4
Company
RED MILAWA PTY. LTD.
Model
XT4
Device description
XT Series Power Wheelchair (XT4)
Published
2024-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K233877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233877000XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility2024-03-04ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09356399060967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09356399060967093563990609679356399060967

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
752816785
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09356399060974Magic XT2XT22024-11-18
09356399000055Magic 360 Electric Wheelchair360Magic 3602021-05-28
09356399000000Frontier Electric WheelchairV4 RWDFrontier V4 RWD2020-02-28
09356399000017Frontier Electric WheelchairV4 FWDFrontier V4 FWD2020-02-28
09356399000024Frontier Electric WheelchairV6Frontier V62020-02-28
09356399000031Frontier Electric WheelchairV6 C73 UrbanFrontier V6 C73 Urban2020-02-28
09356399000048Extreme X8 Electric WheelchairX8Extreme X82020-02-28
B391V60Frontier V6 Electric WheelchairV62017-01-24
B391X80Extreme X8 Electric WheelchairX82017-01-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
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00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
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00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
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