YIWU THOUSAND SHORES E-BUSINESS CO., LTD · 89-08 · CHINA
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html