FDA.reportPublic FDA data

BRYDAN MEDICAL

Primary DI
00853301008080
Brand
BRYDAN MEDICAL
Company
BRYDAN MEDICAL HOLDINGS
Model
12432
Device description
"W/C-SS 24"" width, 350 lb. capacity, forest green uph."
Published
2018-01-03
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
00853301008080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853301008080008533010080808533010080800853301008080

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsibleA wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is 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 cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078612438
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853301008257Brydan Medical900792024-10-15
00853301008264Brydan Medical900942024-10-15
00853301008271Brydan Medical900532024-10-15
00853301008288Brydan Medical900472024-10-15
00853301008295Brydan Medical900862024-10-15
00853301008448Brydan Medical125252024-10-15
00853301008028BRYDAN MEDICAL116292018-01-03
00853301008035BRYDAN MEDICAL115272018-01-03
00863574000445BRYDAN MEDICAL123052017-12-29
00853301008431BRYDAN MEDICAL900512018-01-03
00863574000452BRYDAN MEDICAL122042017-12-29
00853301008011BRYDAN MEDICAL110842017-12-30
00853301008042BRYDAN MEDICAL119452018-01-03
00853301008059BRYDAN MEDICAL118992018-01-03
00853301008066BRYDAN MEDICAL118772018-01-03
00853301008073BRYDAN MEDICAL110972018-01-03
00853301008097BRYDAN MEDICAL900662018-01-03
00863574000438BRYDAN MEDICAL115072018-01-03
00863574000469BRYDAN MEDICAL113672017-12-30
00863574000476BRYDAN MEDICAL999992018-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
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
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31