The following data is part of a premarket notification filed by Ningbo Shenyu Medical Equipment Co., Ltd. with the FDA for Manual Wheelchair, Model A011.
Device ID | K201461 |
510k Number | K201461 |
Device Name: | Manual Wheelchair, Model A011 |
Classification | Wheelchair, Mechanical |
Applicant | Ningbo Shenyu Medical Equipment Co., Ltd. No. 1318 West Of Tanjialing Road Yuyao, CN 315408 |
Contact | Zhou Yuefeng |
Correspondent | Vivi Shi Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, CN 200122 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-02 |
Decision Date | 2021-05-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06950572844110 | K201461 | 000 |