YAMAHA MOTOR CO LTD

FDA Device Registration & Listing · Iwata Shizuoka, JP · Registration 3001185828

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001185828
FEI Number
3001185828
Entity Name
YAMAHA MOTOR CO LTD
City/State/Country
Iwata Shizuoka, JP
Establishment Address
2500 Shingai, Iwata Shizuoka 4388501, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
YAMAHA MOTOR CO LTD (Owner Number: 10047594)
Owner / Operator Contact Address
2500 Shingai, Iwata, JP-22 4388501, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K203806
PMA Number
N/A

All Registered Proprietary Names

JWX-1 Plus (Navi Go 16 / Navi Go 24)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2021-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

Rob Trester Business: Yamaha Motor Corporation, USA Email: Rob_Trester@yamaha-motor.com Phone: (714) 7617346

Related Public Records

Same Entity

YAMAHA MOTOR CO LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001185828. Last updated year: 2026. Please use registration number 3001185828 when referencing this establishment in official correspondence.
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