FDA.reportPublic FDA data

Assembly Required Distributors

Primary DI
00854362008293
Brand
Assembly Required Distributors
Company
Assembly Required Distributors Inc
Model
WCM1825FF27
Device description
"Stainless Steel W/C, 18"" width, removable full length arm, fixed footrest, burgandy, no IV pole"
Published
2018-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973418000UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)Assembly Required Dist., Inc.1997-10-09IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854362008293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854362008293008543620082938543620082930854362008293

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, 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 manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170562396
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004575672Assembly Required Distributors IncWAM3000-012025-04-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31