FDA.reportPublic FDA data

BRYDAN MEDICAL

Primary DI
00863574000452
Brand
BRYDAN MEDICAL
Company
BRYDAN MEDICAL HOLDINGS
Model
12204
Device description
Bariatric Walkeradj height: 32' - 38-1/2
Published
2017-12-29
Public version status
Update
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
00863574000452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863574000452008635740004528635740004520863574000452

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable, extra wide framework with handgrips and four legs designed to provide a stable support for a bariatric (obese) person when standing or ambulating; it may also be used during rehabilitation. It is a sturdy construction made of lightweight metal, plastic, and rubber materials that surrounds the front and flanks of the user. The user holds the handgrips to push the device in front of them as they move forward. The device is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078612438
Device count
1
Premarket exempt
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
00853301008011BRYDAN MEDICAL110842017-12-30
00853301008042BRYDAN MEDICAL119452018-01-03
00853301008059BRYDAN MEDICAL118992018-01-03
00853301008066BRYDAN MEDICAL118772018-01-03
00853301008073BRYDAN MEDICAL110972018-01-03
00853301008080BRYDAN MEDICAL124322018-01-03
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
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
00815027011867DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027011881DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027012888DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
B845X1021WOTUREIntco Medical Industries, Inc.ITJ2025-08-20
B845X3011WOTUREIntco Medical Industries, Inc.ITJ2025-06-13