SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD · 89-08 · CHINA
For SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is PowerUp Penis Pump; product code is 78 L - - KY Device, External Penile Rigidity; date published is 04/20/2016; address is Guihua Rd , No. 302 Guanlan; Guanlanzhen Longgangcommunity , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Guihua Rd , No. 302 Guanlan; Guanlanzhen Longgangcommunity , Shenzhen, Guangdong CHINA verified
- Date published
- 04/20/2016 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- PowerUp Penis Pump verified
What the source says
SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD Date Published : 04/20/2016 Guihua Rd , No. 302 Guanlan; Guanlanzhen Longgangcommunity , Shenzhen, Guangdong CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
78 L - - KY Device, External Penile Rigidity Date Published: 04/20/2016 Desc: PowerUp Penis Pump
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html