# Suzhou Armocon Technology Co.Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Suzhou Armocon Technology 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 Penis Ring; product code is 78 L - - KY Device, External Penile Rigidity; date published is 12/10/2012; address is D, Sip F 3 , No. 77 Suhong Middle Rd; Zhongxin Gongyeyuan , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Suzhou Armocon Technology 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:** D, Sip F 3 , No. 77 Suhong Middle Rd; Zhongxin Gongyeyuan , Suzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 12/10/2012 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity _(verified: appears in the quote below)_
- **Product:** Penis Ring _(verified: appears in the quote below)_
- **FDA notes:** Class II; 12/10/12 _(verified: appears in the quote below)_

## What the source says

> Suzhou Armocon Technology Co.Ltd Date Published : 12/10/2012 D, Sip F 3 , No. 77 Suhong Middle Rd; Zhongxin Gongyeyuan , Suzhou, Jiangsu CHINA 78 L - - KY Device, External Penile Rigidity Date Published: 05/22/2014 Desc: Penis Ring Notes: Class II; 12/10/12

## 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/).