Miracle International Co. Ltd · 89-08 · CHINA
For Miracle International 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 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 2026-09-30.
- Firm
- Miracle International 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
- Qilin Middle Rd , Guangzhou, Guangdong CHINA verified
- Date published
- 09/10/2010 verified
- Product code
- 80 L - - DQ Device, General Medical verified
- Product
- Executive Ion Detox Machine (TENS Unit; Far Infrared Belt; and Ion Detox) verified
- FDA notes
- Class II verified
What the source says
Miracle International Co. Ltd Date Published : 09/10/2010 Qilin Middle Rd , Guangzhou, Guangdong 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html