The following data is part of a premarket notification filed by Jiangsu Intco Medical Products Co., Ltd. with the FDA for Y207 Electric Wheelchair.
Device ID | K202482 |
510k Number | K202482 |
Device Name: | Y207 Electric Wheelchair |
Classification | Wheelchair, Powered |
Applicant | Jiangsu Intco Medical Products Co., Ltd. No. 77 Yandunshan Road Dagang Zhenjiang, CN 212132 |
Contact | Wang Maokun |
Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, No.1500, Century Ave., Pudong New District Shanghai, CN 200122 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-28 |
Decision Date | 2021-03-18 |