Suzhou Armocon Technology Co.Ltd · 89-08 · CHINA
For Suzhou Armocon Technology Co.Ltd, import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
78 L - - KY Device, External Penile Rigidity Date Published: 05/22/2014 Desc: Penis Ring Notes: Class II; 12/10/12
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html