# Tuos International Trade · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Xiaojing Village , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 03/12/2014 _(verified: appears in the quote below)_
- **Product code:** 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) | Transcutaneous Electrical Nerve Stimulator (Portable High Frequency) _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## 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

## 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/).