JWX-1 Plus (Navigo 16/Navigo 24)— 510(k) K203806

Substantially Equivalent

Yamaha Motor Co., Ltd.

FDA 510(k) clearance K203806 for JWX-1 Plus (Navigo 16/Navigo 24), Substantially Equivalent on 2021-05-21. Applicant: Yamaha Motor Co., Ltd..

Clearance details

Applicant: Yamaha Motor Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2020-12-28
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iwata, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.