FDA.reportPublic FDA data

Extreme X8 Electric Wheelchair

Primary DI
B391X80
Brand
Extreme X8 Electric Wheelchair
Company
RED MILAWA PTY. LTD.
Model
X8
Device description
Extreme X8 Electric Wheelchair
Published
2017-01-24
Public version status
Update
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
K090350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090350000EXTREME 4X4-X8 POWER WHEELCHAIRVestil Manufacturing Corp.2009-04-10ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B391X80PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752816785
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09356399060967 Magic XT4XT42024-11-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
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00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
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
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