Tega Industrial Company Ltd. · 89-08 · HONG KONG SAR
For Tega Industrial Company Ltd., 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 Day Light Bright Light Therapy Systems; product code is 80 M - - IO Light, Therapy, Sad(Seasonal Affective Disorder); date published is 10/20/2010; address is Room 1202 , Harbour Centre Tower 2; 8 Hok Cheung Street , Hung Hom, Kowloon HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Tega Industrial Company Ltd. 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
- Room 1202 , Harbour Centre Tower 2; 8 Hok Cheung Street , Hung Hom, Kowloon HONG KONG SAR verified
- Date published
- 10/20/2010 verified
- Product code
- 80 M - - IO Light, Therapy, Sad(Seasonal Affective Disorder) verified
- Product
- Day Light Bright Light Therapy Systems verified
- FDA notes
- Class II verified
What the source says
Tega Industrial Company Ltd. Date Published : 10/20/2010 Room 1202 , Harbour Centre Tower 2; 8 Hok Cheung Street , Hung Hom, 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
80 M - - IO Light, Therapy, Sad(Seasonal Affective Disorder) Date Published: 10/20/2010 Desc: Day Light Bright Light Therapy Systems 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