FDA 510(k)

JWX-1 Plus (Navigo 16/Navigo 24)

K-Number: K203806 · 2021-05-21

Decision Date2021-05-21

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

JWX-1 Plus (Navigo 16/Navigo 24) is a medical device manufactured by Yamaha Motor Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under approval number K203806. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JWX-1 Plus (Navigo 16/Navigo 24)?

JWX-1 Plus (Navigo 16/Navigo 24) is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by Yamaha Motor Co., Ltd.. The 510(k) number is K203806.

When was JWX-1 Plus (Navigo 16/Navigo 24) approved by the FDA?

JWX-1 Plus (Navigo 16/Navigo 24) received FDA 510(k) clearance on 2021-05-21, under approval number K203806.

What company makes JWX-1 Plus (Navigo 16/Navigo 24)?

JWX-1 Plus (Navigo 16/Navigo 24) is manufactured by Yamaha Motor Co., Ltd..

What is the FDA product code for JWX-1 Plus (Navigo 16/Navigo 24)?

The FDA product code for JWX-1 Plus (Navigo 16/Navigo 24) is ITI.

Other Devices by Yamaha Motor Co., Ltd.

K252101JWG-1

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.