FDA.reportPublic FDA data

none

Primary DI
06975960550558
Brand
none
Company
Zhejiang Mateside Medical Devices Technology Co., Ltd
Model
AX35
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNGLift, Patient, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975960550558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975960550558069759605505586975960550558

GMDN Terms#

Term, Definition table
TermDefinition
Stand-assistive attendant-only-propelled wheelchairAn electrically-powered device designed to be used by a healthcare provider for: 1) manual (non-electric) transport of a non-bariatric patient with a disability, or without the full capacity to walk, in a seated position over a short distance (indoors or over smooth paved surfaces); and 2) electronically-assisted patient standing. It is designed as a wheelchair with small caster wheels (inadequate for occupant self-propulsion) and a seat-lifting/footrest-lowering electronic stand-assistive mechanism; it cannot be folded or readily dismantled for transport. It is typically used in hospitals and institutions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
699411523
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975960550749noneZ272026-05-25
06975960550701noneZ362026-03-24
06975960550671VOCICXZY082026-03-17
06975960550565noneAX252026-01-15
06975960550589noneAX162026-01-15
06975960550602noneZ252026-01-15
06975960551470VOCICZ352026-01-04
06975960551487VOCICZ122026-01-04
06975960551463VOCICZ652025-12-03
06975960558677noneYR11-A-BL-X2025-09-11
06975960558639noneAY07-A2025-08-14
06975960551401VOCICZ512025-06-18
06975960551418VOCICZ522025-06-18
06975960558394VOCICZ732025-04-01
06975960551388VOCICZ112025-04-29
06975960550510VOCICAX082025-06-04
06975960550527VOCICAX092025-05-19
06975960551395VOCICJC35M32025-04-30
06975960551371maidesiteEN112025-03-26
06975960551265VOCIC or MatesideAX122025-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975960550565noneZhejiang Mateside Medical Devices Technology Co., LtdFNG2026-01-15
00860014621864ValmaxSupply Line MedicalFNG2025-12-22
06975960550510VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-06-04
06975960550527VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-05-19
06975960551395VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-04-30
00810178880522ViveVIVE HEALTH LLCFNG2025-04-04
00810178880706ViveVIVE HEALTH LLCFNG2025-04-04
10810178880529ViveVIVE HEALTH LLCFNG2025-04-04
10810178880703ViveVIVE HEALTH LLCFNG2025-04-04
06975960551357maidesiteZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-01-16
06977918410099AireMedJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-12-03
06977918410037SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410044SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410051SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410068SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410075SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
06977918410082SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
05060405748520GBUK LtdGBUK LTDFNG2024-11-08
05060405747554GBUK LtdGBUK LTDFNG2024-11-07
00860004936824EasyBoost 400Seneca Devices, Inc.FNG2024-10-17
00860004936831EasyBoostSeneca Devices, Inc.FNG2024-07-31
00860004936855EasyBoostSeneca Devices, Inc.FNG2024-07-09
05060405747837BananaGBUK LTDFNG2024-01-22
M368GT5XL1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368GT5XLC1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL10001GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL1000S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL7001GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL700S1GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04
M368PL8001GENDRONGF HEALTH PRODUCTS, INC.FNG2023-12-04