The following data is part of a premarket notification filed by Kunshan Hi-fortune Health Products Co.,ltd. with the FDA for Wheelchair.
Device ID | K163352 |
510k Number | K163352 |
Device Name: | Wheelchair |
Classification | Wheelchair, Mechanical |
Applicant | Kunshan Hi-Fortune Health Products Co.,Ltd. No. 301, Qinhe Road, Zhangpu Town Kunshan, CN 215300 |
Contact | Hongfa Zhi |
Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. Liyuan Town, Tongzhou District, Beijing, CN 101121 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-30 |
Decision Date | 2017-07-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WHEELCHAIR 81045528 1045528 Dead/Cancelled |
National Paraplegia Foundation 0000-00-00 |