# YIWU THOUSAND SHORES E-BUSINESS CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For YIWU THOUSAND SHORES E-BUSINESS 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 Ohuhu Tens And Powered Muscle Stimulator Model AS1080 | Ohuhu Tens And Powered Muscle Stimulator Model AS1080 | Ohuhu Tens And Powered Muscle Stimulator Model AS1080; product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 07/21/2025; address is Building 3 9th Floor , No. 315 Hongyun Road, Chengxi Street; Commerce Town , Yiwu, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** YIWU THOUSAND SHORES E-BUSINESS CO., LTD _(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:** Building 3 9th Floor , No. 315 Hongyun Road, Chengxi Street; Commerce Town , Yiwu, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 07/21/2025 _(verified: appears in the quote below)_
- **Product code:** 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning _(verified: each item appears in the quote below)_
- **Product:** Ohuhu Tens And Powered Muscle Stimulator Model AS1080 | Ohuhu Tens And Powered Muscle Stimulator Model AS1080 | Ohuhu Tens And Powered Muscle Stimulator Model AS1080 _(verified: each item appears in the quote below)_
- **FDA notes:** Class I | Class I | Class I _(verified: each item appears in the quote below)_

## What the source says

> YIWU THOUSAND SHORES E-BUSINESS CO., LTD Date Published : 07/21/2025 Building 3 9th Floor , No. 315 Hongyun Road, Chengxi Street; Commerce Town , Yiwu, Zhejiang CHINA 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 07/21/2025 Desc: Ohuhu Tens And Powered Muscle Stimulator Model AS1080 Notes: Class I 89 I - - SA Massager, Therapeutic, Electric Date Published: 07/21/2025 Desc: Ohuhu Tens And Powered Muscle Stimulator Model AS1080 Notes: Class I 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 07/21/2025 Desc: Ohuhu Tens And Powered Muscle Stimulator Model AS1080 Notes: Class I

## 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/).