FDA.reportPublic FDA data

NAVIGO

Primary DI
04580027190091
Brand
NAVIGO
Company
YAMAHA MOTOR CO., LTD.
Model
X0FD
Published
2021-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K203806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203806000JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd.2021-05-21ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580027190091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580027190091045800271900914580027190091

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair electric-motor-driven propulsion systemAn assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-229-7959info@yamahanavi.com

Regulatory Flags#

DUNS number
690536081
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580027190206NAVIONEX0EJ2024-07-16
04580027190213NAVIONEX0EJ2024-07-16
04580027190220NAVIONEX0EJ2024-07-16
04580027190237NAVIONEX0EJ2024-07-16
04580027190244NAVIONEX0EJ2024-07-16
04580027190077NAVIGOX0FC2021-12-07
04580027190084NAVIGOX0FD2021-12-07
04580027190060NAVIGOX0FC2021-12-06
04580027190015NAVIONEX0EJ2018-04-03
04580027190022NAVIONEX0EJ2018-04-03
04580027190039NAVIONEX0EJ2018-04-03
04580027190046NAVIONEX0EJ2018-04-03
04580027190053NAVIONEX0EJ2018-04-03

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