FDA.reportPublic FDA data

ZIP’r 3

Primary DI
06972356130028
Brand
ZIP’r 3
Company
GLOBAL FABTECH (SHANGHAI) CO., LTD.
Model
01
Device description
Zip'r 3 Wheel Traveler Mobility Scooter blue
Published
2023-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INIVehicle, Motorized 3-Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102358000ZIP'R3/ ZIP'R3 XTRA SCOOTERGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.2010-10-04INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972356130028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972356130028069723561300286972356130028

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529966574
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972356130011ZIP’r 3012023-09-24
06972356130035Zip'r 4012023-09-24
06972356130042Zip'r 4012023-09-24
06972356130059ZIP’r 3012023-09-24
06972356130066ZIP’r 3012023-09-24
06972356130073Zip'r 4012023-09-24
06972356130080Zip'r 4012023-09-24
06972356130103Zip'r 4012023-09-24
06972356130110Zip'r 4012023-09-24
06972356130127Zip'r 4012023-09-24
06972356130134Zip'r 4012023-09-24
06972356130141Zip'r 4012023-09-24
06972356130172ZIP’r Mantis012023-09-24
06972356130189ZIP’r Mantis012023-09-24
06972356130196ZIP’r Mantis012023-09-24
06972356130202ZIP’r Mantis012023-09-24
06972356130004ZIP’r PC012023-09-19
06972356130097ZIP’r PC012023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973175531348MOGOAnhui JBH Medical Apparatus Co., Ltd.INI2026-05-09
06978949462149Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-04-29
06978746860155Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978746860162Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978949462507Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463061Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463078Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463085Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
00606509300919Go Go Super Portable 2Pride Mobility Products CorpINI2026-03-19
00606509300926Go Go Super Portable HDPride Mobility Products CorpINI2026-03-19
06974857293004Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293011Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293301Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293318Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857295800Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06978074600003MIJONanjing Mijo Technology Co., LtdINI2026-03-17
00810203611008ComfyGOComfyGO, IncINI2026-03-10
04719873857661KarmaKARMA MEDICAL PRODUCTS CO., LTD.INI2026-02-25
00606509300865Baja Wrangler 3Pride Mobility Products CorpINI2026-02-17
00606509300872Ultra X GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300889Elite Traveller GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumPride Mobility Products CorpINI2026-02-17
06972665816002Nanjing Kangni Smart Technology Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.INI2026-02-11
06970990830694SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830700SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830717SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830724SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06975185620173BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDINI2026-01-07
04713072962379FREERIDERFREERIDER CORP.INI2026-01-02
04713072962386FREERIDERFREERIDER CORP.INI2026-01-02