FDA.reportPublic FDA data

Amigo

Primary DI
00863048000308
Brand
Amigo
Company
AMIGO MOBILITY INTERNATIONAL, INC.
Model
RD
Device description
Amigo RD
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
INFScale, Platform, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INFScale, Platform, WheelchairPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K871391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871391000AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)Amigo Sales, Inc.1987-05-06INF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863048000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863048000308008630480003088630480003080863048000308

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
00863048000315AmigoRT Express2016-09-26
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
00849987000579SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001262SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001279SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001286SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001293SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001309SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001316SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001323SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001330SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001347SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001354SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001361SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001378SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001491SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001552SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001569SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001576SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001583SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001590SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001606SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001613SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001620SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001811SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987001989SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002153SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002160SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002177SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002184SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002368SR ScalesS R INSTRUMENTS, INC.INF2026-06-22
00849987002382SR ScalesS R INSTRUMENTS, INC.INF2026-06-22