FDA.reportPublic FDA data

GAESCA

Primary DI
00850051333295
Brand
GAESCA
Company
Mp2g Diagnostic Corp
Model
"Gaesca Transportation Wheelchair 22"" Width"
Device description
"Transportation Wheelchair 22"" Width"
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K041814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041814000FS SERIES WHEELCHAIRFoshan Dongfang Medical Equipment Manufactory(Ltd)2004-07-20IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051333295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051333295008500513332958500513332950850051333295

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, bariatricA non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person without the full capacity to walk to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048991263
Device count
1

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
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
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

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