Suzhou Armocon Technology Co.Ltd · 89-08 · CHINA
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
- 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
- D, Sip F 3 , No. 77 Suhong Middle Rd; Zhongxin Gongyeyuan , Suzhou, Jiangsu CHINA verified
- Date published
- 12/10/2012 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- Penis Ring verified
- FDA notes
- Class II; 12/10/12 verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.