Shenzhen Huirun Import & Export Co · 89-08 · CHINA
For Shenzhen Huirun Import & Export Co, 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 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 2026-09-30.
- Firm
- Shenzhen Huirun Import & Export Co 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
- Nanshan Road 1017lianhua International , Shenzhen, CHINA verified
- Date published
- 05/14/2012 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) each item verified
- Product
- Penis Enlarger and Penis Extender | Penis Enlarger and Penis Extender each item verified
- FDA notes
- Class II | class II each item verified
What the source says
Shenzhen Huirun Import & Export Co Date Published : 05/14/2012 Nanshan Road 1017lianhua International , Shenzhen, 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: 05/14/2012 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html