FDA.reportPublic FDA data

GAESCA

Primary DI
00850051333264
Brand
GAESCA
Company
Mp2g Diagnostic Corp
Model
Gaesca Aluminium Foldable Walker with Wheels
Device description
Aluminium Foldable Walker with Wheels
Published
2023-05-31
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
00850051333264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051333264008500513332648500513332640850051333264

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
00850051333240GAESCA"Gaesca Steel Foldable Rollator 8"" PVC Castor Whe2023-05-05
00850051333257GAESCA"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

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Primary DI, Brand, Company table
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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
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