# Shenzhen Huirun Import & Export Co · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Huirun Import & Export Co · 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 Penis Enlarger and Penis Extender | Penis Enlarger and Penis Extender; product code is 78 L - - KY Device, External Penile Rigidity | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered); date published is 05/14/2012; address is Nanshan Road 1017lianhua International , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Huirun Import & Export Co _(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:** Nanshan Road 1017lianhua International , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 05/14/2012 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) _(verified: each item appears in the quote below)_
- **Product:** Penis Enlarger and Penis Extender | Penis Enlarger and Penis Extender _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Shenzhen Huirun Import & Export Co Date Published : 05/14/2012 Nanshan Road 1017lianhua International , Shenzhen, CHINA 78 L - - KY Device, External Penile Rigidity Date Published: 05/14/2012 Desc: Penis Enlarger and Penis Extender Notes: Class II 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) Date Published: 05/14/2012 Desc: Penis Enlarger and Penis Extender Notes: class II

## 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/).