Clearance Summary
JWX-1 Plus (Navigo 16/Navigo 24) received FDA 510(k) clearance under submission number K203806, sponsored by Yamaha Motor Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2021-05-21.
- Submission: K203806
- Applicant / Sponsor: Yamaha Motor Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2021-05-21
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.