Asia Unlimited · 89-08 · HONG KONG SAR
For Asia Unlimited, import alert is 89-08; country is HONG KONG SAR; 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 code is 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/16/2009; address is Unknown , Hong Kong, HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Asia Unlimited 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
- HONG KONG SAR verified
- Address
- Unknown , Hong Kong, HONG KONG SAR verified
- Date published
- 09/16/2009 verified
- Product code
- 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) verified
- FDA notes
- The Shealy RelaxMate (aka RelaxEase) 8/27/1998 verified
What the source says
Asia Unlimited Date Published : 09/16/2009 Unknown , Hong Kong, HONG KONG SAR
— 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 and FDA notes
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/16/2009 Notes: The Shealy RelaxMate (aka RelaxEase) 8/27/1998
— all from 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.