# SHENZHEN CANWIN HEALTH PRODUCTS CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Guihua Rd , No. 302 Guanlan; Guanlanzhen Longgangcommunity , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/20/2016 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity _(verified: appears in the quote below)_
- **Product:** PowerUp Penis Pump _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).