# HSIN TEN ENTERPRISES MEXICO · 89-08 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For HSIN TEN ENTERPRISES MEXICO · 89-08 · MEXICO, 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 MEXICO; 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 2026-09-16.

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

## 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 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

## 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/).