The following data is part of a premarket notification filed by Yamaha Motor Co., Ltd. with the FDA for Jwx-2.
| Device ID | K140204 |
| 510k Number | K140204 |
| Device Name: | JWX-2 |
| Classification | Wheelchair, Powered |
| Applicant | YAMAHA MOTOR CO., LTD. 882 SOUDE, NAKA-KU Hamamatsu, Shizuoka, JP 435-0054 |
| Contact | Masanori Yonemitsu |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05022408056767 | K140204 | 000 |
| 04580027190053 | K140204 | 000 |
| 04580027190046 | K140204 | 000 |
| 04580027190039 | K140204 | 000 |
| 04580027190022 | K140204 | 000 |
| 04580027190015 | K140204 | 000 |