JWX-1 Plus (Navigo 16/Navigo 24)

Wheelchair, Powered

Yamaha Motor CO., LTD.

The following data is part of a premarket notification filed by Yamaha Motor Co., Ltd. with the FDA for Jwx-1 Plus (navigo 16/navigo 24).

Pre-market Notification Details

Device IDK203806
510k NumberK203806
Device Name:JWX-1 Plus (Navigo 16/Navigo 24)
ClassificationWheelchair, Powered
Applicant Yamaha Motor CO., LTD. 2500 Shingai Iwata,  JP 438-8501
ContactMichiyo Yamazaki
CorrespondentMikio Saitou
Yamaha Motor CO., LTD. 2500 Shingai Iwata,  JP 438-8501
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-05-21

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