FDA.reportPublic FDA data

Assembly Required Distributors Inc

Primary DI
00860004575672
Brand
Assembly Required Distributors Inc
Company
Assembly Required Distributors Inc
Model
WAM3000-01
Device description
Knee Walker - aluminum
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004575672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004575672008600045756728600045756720860004575672

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170562396
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004575658Assembly Required Distributors Inc.AC1507-012023-07-06
00860004575665Assembly Required DistributorsWAM2000-012025-02-15
00854362008798Assembly Required DistributorsFSM1729-012024-10-03
00854362008637Assembly Required DistributorsCHM8905-012018-08-27
00854362008644Assembly Required DistributorsCHM8917-012018-08-27
00854362008651Assembly Required DistributorsCHM8903-012018-08-27
00854362008668Assembly Required DistributorsCHM8904-012018-08-27
00854362008675Assembly Required DistributorsCHM8906-012018-08-27
00854362008682Assembly Required DistributorsCHM8919-502018-08-27
00854362008699Assembly Required DistributorsCHM8907-012018-08-27
00854362008705Assembly Required DistributorsCHM8927-012018-08-28
00854362008712Assembly Required DistributorsCHM8086-012018-08-28
00854362008729Assembly Required DistributorsCHM8087-012018-10-03
00854362008736Assembly Required DistributorsCHM8911-012018-10-03
00854362008743Assembly Required DistributorsCHM8909-012018-10-03
00854362008750Assembly Required DistributorsCHM8923-012018-10-03
00854362008767Assembly Required DistributorsCHM8058-012018-10-03
00854362008774Assembly Required DistributorsCHM8907-012018-10-03
00854362008446Assembly Required DistributorsFSM1724-012018-10-22
00854362008453Assembly Required DistributorsFSM1746-012018-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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