Century International · 89-08 · HONG KONG SAR
For Century International · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Hothouse FIR Health Builder; product code is 89 I - - OB Lamp, Infrared, Physical Medicine; date published is 09/16/2009; address is Flat/Rm 701 Sino Ctr 582-592 , 5825 Nathan Road , Mong Kok, Kowloon HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- Century International 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
- Flat/Rm 701 Sino Ctr 582-592 , 5825 Nathan Road , Mong Kok, Kowloon HONG KONG SAR verified
- Date published
- 09/16/2009 verified
- Product code
- 89 I - - OB Lamp, Infrared, Physical Medicine verified
- Product
- Hothouse FIR Health Builder verified
- FDA notes
- Reason; Lacks 510(k); 11/26/2001 verified
What the source says
Century International Date Published : 09/16/2009 Flat/Rm 701 Sino Ctr 582-592 , 5825 Nathan Road , Mong Kok, Kowloon HONG KONG SAR 89 I - - OB Lamp, Infrared, Physical Medicine Date Published: 01/23/2019 Desc: Hothouse FIR Health Builder Notes: Reason; Lacks 510(k); 11/26/2001
— 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.