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 |