# SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination 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: 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:** Block B # 803 , Houtingcun; Baoan , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_ - **Date published:** 03/20/2025 _(verified: appears in the quote below)_ - **Product code:** 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - -- Portion of device code _(verified: each item appears in the quote below)_ - **Product:** AVCOO TENS/EMS Model AS9020 | AVCOO TENS/EMS Model AS9020 _(verified: each item appears in the quote below)_ - **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 _(verified: each item appears in the quote below)_ ## 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 ## 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/).