FDA.reportPublic FDA data

Amigo

Primary DI
00863048000322
Brand
Amigo
Company
AMIGO MOBILITY INTERNATIONAL, INC.
Model
HD
Device description
Amigo HD
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
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
00863048000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863048000322008630480003228630480003220863048000322

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
00863048000315AmigoRT Express2016-09-26
00863048000339AmigoClassic FD2016-09-26
00863048000346AmigoEscort 7.52016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719846017313CharderCHARDER ELECTRONIC CO., LTD.INF2026-05-13
04719846017245CharderCHARDER ELECTRONIC CO., LTD.INF2026-04-23
04719846016774CharderCHARDER ELECTRONIC CO., LTD.INF2025-11-27
04719846016705CharderCHARDER ELECTRONIC CO., LTD.INF2025-11-13
04012030021531seca 620seca GmbH & Co. KGINF2025-11-01
04719846013995CharderCHARDER ELECTRONIC CO., LTD.INF2023-08-10
04719846013711CharderCHARDER ELECTRONIC CO., LTD.INF2023-04-07
04719846013667CharderCHARDER ELECTRONIC CO., LTD.INF2023-02-23
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00850042373644HealthweighRice Lake Weighing Systems, Inc.INF2022-12-21
00850042373071HealthweighRice Lake Weighing Systems, Inc.INF2022-12-12