SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. · 89-08 · CHINA
For SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY 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 AVCOO TENS/EMS Model AS9020 | AVCOO TENS/EMS Model AS9020; product code is 84 N - - -- Portion of device code | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter; date published is 03/20/2025; address is Block B # 803 , Houtingcun; Baoan , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- 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 - - -- Portion of device code | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter 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
— accessdata.fda.gov, retrieved 2026-09-22
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 - - -- 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 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html