SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. · 89-08 · CHINA
For SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY 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 AVCOO TENS/EMS Model AS9020 | AVCOO TENS/EMS Model AS9020; product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - -- Portion of device code; date published is 03/20/2025; address is Block B # 803 , Houtingcun; Baoan , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY 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
- Block B # 803 , Houtingcun; Baoan , Shenzhen, Guangdong CHINA verified
- Date published
- 03/20/2025 verified
- Product code
- 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - -- Portion of device code each item verified
- Product
- AVCOO TENS/EMS Model AS9020 | AVCOO TENS/EMS Model AS9020 each item verified
- FDA notes
- Subject device appears to have design changes and labeling outside the scope of the declared clearance | Subject device appears to have design changes and labeling outside the scope of the declared clearance each item verified
What the source says
SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. Date Published : 03/20/2025 Block B # 803 , Houtingcun; Baoan , Shenzhen, Guangdong CHINA 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 03/20/2025 Desc: AVCOO TENS/EMS Model AS9020 Notes: Subject device appears to have design changes and labeling outside the scope of the declared clearance 84 N - - -- Portion of device code Date Published: 03/20/2025 Desc: AVCOO TENS/EMS Model AS9020 Notes: Subject device appears to have design changes and labeling outside the scope of the declared clearance
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.