Tuos International Trade · 89-08 · CHINA
For Tuos International Trade, 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html