iBOT(R)

GUDID 00857584008010

iBOT® Personal Mobility Device - Wheelchair, Stair Climbing

MOBIUS MOBILITY LLC

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Primary Device ID00857584008010
NIH Device Record Keyf77641ad-8d97-454a-9452-91d7a6b3b4ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameiBOT(R)
Version Model NumberiBOT PMD
Company DUNS081155071
Company NameMOBIUS MOBILITY LLC
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857584008010 [Primary]

FDA Product Code

IMKWheelchair, Stair Climbing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-14
Device Publish Date2022-06-06

Devices Manufactured by MOBIUS MOBILITY LLC

00857584008010 - iBOT(R)2022-06-14iBOT® Personal Mobility Device - Wheelchair, Stair Climbing
00857584008010 - iBOT(R)2022-06-14 iBOT® Personal Mobility Device - Wheelchair, Stair Climbing
00857584008003 - iBOT2020-01-16 iBOT® Personal Mobility Device - Wheelchair, Stair Climbing

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