Miracle International Co. Ltd · 89-08 · CHINA
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.