# Century International · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Flat/Rm 701 Sino Ctr 582-592 , 5825 Nathan Road , Mong Kok, Kowloon HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 89 I - - OB Lamp, Infrared, Physical Medicine _(verified: appears in the quote below)_
- **Product:** Hothouse FIR Health Builder _(verified: appears in the quote below)_
- **FDA notes:** Reason; Lacks 510(k); 11/26/2001 _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).