YIWU THOUSAND SHORES E-BUSINESS CO., LTD · 89-08 · CHINA
For YIWU THOUSAND SHORES E-BUSINESS CO., LTD, 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 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 2026-09-30.
- Firm
- YIWU THOUSAND SHORES E-BUSINESS 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
- Building 3 9th Floor , No. 315 Hongyun Road, Chengxi Street; Commerce Town , Yiwu, Zhejiang CHINA verified
- Date published
- 07/21/2025 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Class I | Class I | Class I each item verified
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
— 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html