JWG-1
K-Number: K252101 · 2026-03-19
ApplicantYamaha Motor Co., Ltd.
Decision Date2026-03-19
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
JWG-1 is a medical device manufactured by Yamaha Motor Co., Ltd.. It received FDA 510(k) clearance on 2026-03-19 under approval number K252101. 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 JWG-1?
JWG-1 is a medical device that received FDA 510(k) clearance on 2026-03-19. It is manufactured by Yamaha Motor Co., Ltd.. The 510(k) number is K252101.
When was JWG-1 approved by the FDA?
JWG-1 received FDA 510(k) clearance on 2026-03-19, under approval number K252101.
What company makes JWG-1?
JWG-1 is manufactured by Yamaha Motor Co., Ltd..
What is the FDA product code for JWG-1?
The FDA product code for JWG-1 is ITI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.