Reference Source

Hsin Ten Health & Wealth Industry (Hefei) Co., Ltd. · 89-08 · CHINA

For Hsin Ten Health & Wealth Industry (Hefei) Co., Ltd., import alert is 89-08; country is CHINA; 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 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - OB Lamp, Infrared, Physical Medicine; date published is 09/16/2009; address is 669 Changjiangxilu , Hefei, Anhui CHINA, verified against its source on 2026-09-30.

Firm
Hsin Ten Health & Wealth Industry (Hefei) Co., 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
CHINA verified
Address
669 Changjiangxilu , Hefei, Anhui CHINA verified
Date published
09/16/2009 verified
Product code
89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - OB Lamp, Infrared, Physical Medicine each item verified
FDA notes
4/20/2000 Health Builder | Hothouse FIR Health Builder 11/26/2001 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Hsin Ten Health & Wealth Industry (Hefei) Co., Ltd. Date Published : 09/16/2009 669 Changjiangxilu , Hefei, Anhui CHINA

— 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

89 I - - LY Lamp, infrared, therapeutic heating Date Published: 09/16/2009 Notes: 4/20/2000 Health Builder 89 I - - OB Lamp, Infrared, Physical Medicine Date Published: 09/16/2009 Notes: Hothouse FIR Health Builder 11/26/2001

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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