Reference Source

SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD · 89-08 · CHINA

For SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 78 L - - KY Device, External Penile Rigidity Date Published: 04/20/2016 Desc: PowerUp Penis Pump

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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