The following data is part of a premarket notification filed by Ningbo Lecount Medical Technology Co., Ltd. with the FDA for Nuocande Plastic Manual Wheelchair Model Nkd L07.
Device ID | K151797 |
510k Number | K151797 |
Device Name: | Nuocande Plastic Manual Wheelchair Model NKD L07 |
Classification | Wheelchair, Mechanical |
Applicant | NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. 57 LONGFEI ROAD, YUNLONG INDUSTRY ZONE, YINGZHOU DISTRICT Ningbo, CN 315135 |
Contact | Charles Shen |
Correspondent | Charles Shen Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-02 |
Decision Date | 2015-08-25 |
Summary: | summary |