FDA.reportPublic FDA data

Innuovo

Primary DI
06970765970914
Brand
Innuovo
Company
Zhejiang Innuovo Rehabilitation Devices Co., Ltd
Model
N5513A-091
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070501000RUIKE 3421 POWERED WHEELCHAIRShanghai Ruike Sports Goods Co., Ltd.2007-03-22ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970765970914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970765970914069707659709146970765970914

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, power-assisted, attendant/occupant-controlled, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the pushing and pulling of handles by an attendant or by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544392592
Device count
1

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
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351364BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29