Reference Source

HSIN TEN ENTERPRISES MEXICO · 89-08 · MEXICO

For HSIN TEN ENTERPRISES MEXICO, import alert is 89-08; country is MEXICO; 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 Acupuntador; product code is 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 08/30/2013; address is Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO, verified against its source on 2026-09-30.

Firm
HSIN TEN ENTERPRISES MEXICO 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
MEXICO verified
Address
Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO verified
Date published
08/30/2013 verified
Product code
89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy verified
Product
Acupuntador verified
FDA notes
class II; 8/30/2013 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 ENTERPRISES MEXICO Date Published : 08/30/2013 Calle Licenciado Jose Benitez 2704 , Col. Obispado, Monterrey , Monterrey, Nuevo Leon MEXICO

— 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 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 04/23/2021 Desc: Acupuntador Notes: class II; 8/30/2013

— 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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