Extreme X8 Electric Wheelchair

GUDID B391X80

Extreme X8 Electric Wheelchair

MAGIC MOBILITY

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Primary Device IDB391X80
NIH Device Record Key8a29de16-f1e3-482e-9d18-cdb0ee7c56d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtreme X8 Electric Wheelchair
Version Model NumberX8
Company DUNS752816785
Company NameMAGIC MOBILITY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB391X80 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITIWheelchair, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-24

On-Brand Devices [Extreme X8 Electric Wheelchair]

B391X80Extreme X8 Electric Wheelchair
09356399000048Extreme X8 Electric Four Wheel Drive Wheelchair

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