FDA.reportPublic FDA data

GAESCA

Primary DI
00850051333257
Brand
GAESCA
Company
Mp2g Diagnostic Corp
Model
"Gaesca Steel Foldable Rollator 8"" PVC Castor Whe
Device description
"Steel Foldable Rollator 8"" PVC Castor Wheels (Red)"
Published
2023-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850051333257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051333257008500513332578500513332570850051333257

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
048991263
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051333271GAESCA"Gaesca Steel Rollator 18"" (Red Color)"2025-03-03
00850051333288GAESCA"Gaesca Wheelchair for overweight people - removab2025-03-03
00850051333295GAESCA"Gaesca Transportation Wheelchair 22"" Width"2025-03-03
00850051333301GAESCA"Gaesca Transportation Wheelchair 24"" Width"2025-03-03
00850051333073GAESCAGaesca Standard Wheelchair armrest footrest remova2023-04-27
00850051333080GAESCAGaesca Standard Wheelchair Armrest and Footrest re2023-04-27
00850051333097GAESCAGaesca Standard Basic Portable Wheelchair 220 lbs/2023-04-27
00850051333264GAESCAGaesca Aluminium Foldable Walker with Wheels2023-05-31
00850051333240GAESCA"Gaesca Steel Foldable Rollator 8"" PVC Castor Whe2023-05-05
00850051333004GAESCAGaesca Aluminium Elbow Crutches Standard (Pair)2023-05-04
00850051333011GAESCAGaesca Aluminium Elbow Crutches Gray (Pair)2023-05-04
00850051333028GAESCAGaesca Aluminium Elbow Crutches Blue (Pair)2023-05-04
00850051333035GAESCAGaesca Aluminium Elbow Crutches Black (Pair)2023-05-04
00850051333042GAESCAGaesca Aluminium Basic Crutches S2023-04-27
00850051333059GAESCAGaesca Aluminium Basic Crutches M2023-04-27
00850051333066GAESCAGaesca Aluminium Basic Crutches L2023-04-27
00850051333103GAESCA"Gaesca Aluminium Foldable Rollator 8"" PVC Castor2023-04-27
00850051333110GAESCA"Gaesca Aluminium Foldable Rollator 8"" PVC Castor2023-04-27
00850051333127GAESCAGaesca Aluminium Basic Walker Foldable2023-04-27
00850051333134GAESCAGaesca Aluminium Adjustable Shower Chair w/backres2023-04-27

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