FDA.reportPublic FDA data

Mobility scooter

Primary DI
06970765970006
Brand
Mobility scooter
Company
Zhejiang Innuovo Rehabilitation Devices Co., Ltd
Model
W3331
Published
2016-12-31
Public version status
Update
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
K062676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062676000RUIKE, MODEL 3331Shanghai Ruike Sports Goods Co., Ltd.2006-12-14INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970765970037PackageGS11In Commercial Distribution
06970765970006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970765970037069707659700376970765970037
06970765970006069707659700066970765970006

GMDN Terms#

Term, Definition table
TermDefinition
Assistive three-wheeled mopedA combustion engine, on-road, vehicle with three wheels mounted on a cycle-like frame upon which the user sits astride used to provide a person with a disability with a means of transportation, typically without the attendance of another person, and is designed to be operated by the user. It is typically a standard moped (denoted by the limited engine capacity, e.g., 50cc ? 125cc) with the necessary modifications constructed by a manufacturer who specializes in making such vehicles. This vehicle will enhance the user's independence in short- to medium-range transportation.

Regulatory Flags#

DUNS number
544392592
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978949461999Power WheelchairW59052026-04-29
06978949462040Rallator23072026-04-29
06978949462149Mobility ScooterW39012026-04-29
06978949462743Power WheelchairN59192026-04-29
06978949462835Power WheelchairW55382026-04-29
06978949462927RallatorW2308A2026-04-29
06978949463092Power WheelchairN5515B2026-04-29
06978949462507Mobility ScooterN34732026-03-20
06978949463061Mobility ScooterW3468A2026-03-20
06978949463078Mobility ScooterW34682026-03-20
06978949463085Mobility ScooterW3431D2026-03-20
06978949462538Journey Health & LifestyleN55192025-12-19
06978949462798Mobility ScooterW3331F2025-09-08
06978949462804Mobility ScooterW3431Q2025-09-08
06978949461548RollatorW23012025-08-13
06978949460114Mobility ScooterW33312025-08-12
06978949460169Mobility ScooterW34312025-08-12
06978949460190Mobility ScooterW34312025-08-12
06978949460602Mobility ScooterN3458A2025-08-12
06978949460978Power WheelchairN5513A2025-08-12

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