The following data is part of a premarket notification filed by Kwang Yang Motor Co., Ltd. with the FDA for Foru Kv10hb.
| Device ID | K072027 |
| 510k Number | K072027 |
| Device Name: | FORU KV10HB |
| Classification | Wheelchair, Powered |
| Applicant | KWANG YANG MOTOR CO., LTD. 14F-2, NO.1, ZHUANGJING ROAD LANE 25 Banqiao, TW 220 |
| Contact | Junnata Chang |
| Correspondent | Junnata Chang KWANG YANG MOTOR CO., LTD. 14F-2, NO.1, ZHUANGJING ROAD LANE 25 Banqiao, TW 220 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-24 |
| Decision Date | 2007-08-20 |
| Summary: | summary |