FDA.reportPublic FDA data

Amigo

Primary DI
00863048000315
Brand
Amigo
Company
AMIGO MOBILITY INTERNATIONAL, INC.
Model
RT Express
Device description
Amigo RT Express
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INIVehicle, Motorized 3-Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981121000AMIGO RTAmigo Mobility Intl., Inc.1998-06-30INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863048000315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863048000315008630480003158630480003150863048000315

GMDN Terms#

Term, Definition table
TermDefinition
Assistive scooter, electric-motor-drivenA battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. The device is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160430757
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863048000308AmigoRD2016-09-26
00863048000322AmigoHD2016-09-26
00863048000339AmigoClassic FD2016-09-26
00863048000346AmigoEscort 7.52016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973079880139SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880153SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880337SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880542Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880559Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880566Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880573Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880580Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880597Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880603Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880610Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880627Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880634Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880641Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880658Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
04713072963666FREERIDERFREERIDER CORP.INI2026-07-31
04713072963680FREERIDERFREERIDER CORP.INI2026-07-31
06973079880450IMOVESUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-07-20
00810226441118Vive MobilityVIVE HEALTH LLCINI2026-07-14
06973079880443TRAVEL BUGGYSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-06-14
06973175531348MOGOAnhui JBH Medical Apparatus Co., Ltd.INI2026-05-09
06978949462149Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-04-29
06978746860155Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978746860162Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978949462507Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463061Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463078Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463085Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
00606509300919Go Go Super Portable 2Pride Mobility Products CorpINI2026-03-19
00606509300926Go Go Super Portable HDPride Mobility Products CorpINI2026-03-19