# Miracle International Co. Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Miracle International Co. Ltd · 89-08 · CHINA, 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 CHINA; product is Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox); product code is 80 L - - DQ Device, General Medical; date published is 09/10/2010; address is Qilin Middle Rd , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Miracle International Co. Ltd _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** Qilin Middle Rd , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 09/10/2010 _(verified: appears in the quote below)_
- **Product code:** 80 L - - DQ Device, General Medical _(verified: appears in the quote below)_
- **Product:** Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox) _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Miracle International Co. Ltd Date Published : 09/10/2010 Qilin Middle Rd , Guangzhou, Guangdong CHINA 80 L - - DQ Device, General Medical Date Published: 09/10/2010 Desc: Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox) Notes: Class II

## 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/).