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).
| Device ID | K203806 |
| 510k Number | K203806 |
| Device Name: | JWX-1 Plus (Navigo 16/Navigo 24) |
| Classification | Wheelchair, Powered |
| Applicant | Yamaha Motor CO., LTD. 2500 Shingai Iwata, JP 438-8501 |
| Contact | Michiyo Yamazaki |
| Correspondent | Mikio Saitou Yamaha Motor CO., LTD. 2500 Shingai Iwata, JP 438-8501 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580027190060 | K203806 | 000 |
| 04580027190091 | K203806 | 000 |
| 04580027190084 | K203806 | 000 |
| 04580027190077 | K203806 | 000 |