Chrysalis Intelligence · Sponsors · Yamaha Motor Co., Ltd.

Yamaha Motor Co., Ltd.

Iwata, JP · 2 510(k) clearances · 2 recalls

Total clearances
2
2021-05-21 → 2026-03-19
Last 12 months
1
Product codes
1
Most recent
2026-03-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ITI Wheelchair, Powered Class II Physical Medicine 2 2026-03-19
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2024-04-17
DateSeverityStatusRecall # ProductCodeReason
2024-04-17 Class II Ongoing Z-1816-2024 Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification l…
2024-04-17 Class II Ongoing Z-1815-2024 Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, Y… Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification l…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2026-03-19 K252101 JWG-1 ITI Class II Physical Medicine
2021-05-21 K203806 JWX-1 Plus (Navigo 16/Navigo 24) ITI Class II Physical Medicine