iBOT

Primary DI
00857584008003
Brand
iBOT
Company
MOBIUS MOBILITY LLC
Model
iBOT PMD
Device description
iBOT® Personal Mobility Device - Wheelchair, Stair Climbing
Published
2020-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IMKWheelchair, Stair Climbing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMKWheelchair, Stair ClimbingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172601000Next Generation iBOTDeka Research & Development Corp.2018-03-02IMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857584008003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857584008003008575840080038575840080030857584008003

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
081155071
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857584008010iBOT(R)iBOT PMD2022-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857584008010iBOT(R)MOBIUS MOBILITY LLCIMK2022-06-06