Tuos International Trade · 89-08 · CHINA
For Tuos International Trade · 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 Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) | Transcutaneous Electrical Nerve Stimulator (Portable High Frequency); product code is 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric; date published is 03/12/2014; address is Xiaojing Village , Guangzhou, CHINA, verified against its source on 2026-09-16.
- Firm
- Tuos International Trade 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
- Xiaojing Village , Guangzhou, CHINA verified
- Date published
- 03/12/2014 verified
- Product code
- 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) | Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Tuos International Trade Date Published : 03/12/2014 Xiaojing Village , Guangzhou, CHINA 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 03/12/2014 Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/12/2014 Desc: Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) 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.