Century International · 89-08 · HONG KONG SAR
For Century International, 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html