# Shen Zhen As Tec Technology Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shen Zhen As Tec 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 Auvon TENS Massager - Model AS8016 | Nursal TENS and Powered Muscle Stimulator Model AS1080 | Auvon TENS and Powered Muscle Stimulator Model TA3224 | Auvon TENS Massager - Model AS8012 | Auvon TENS Massager - Model AS8016 | Auvon TENS and Powered Muscle Stimulator Model TA3224 | Auvon TENS Massager - Model AS8012 | Auvon TENS Massager - Model AS8016 | Nursal TENS and Powered Muscle Stimulator Model AS1080; product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 06/15/2016; address is 808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Shen Zhen As Tec 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:** 808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 06/15/2016 _(verified: appears in the quote below)_
- **Product code:** 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning _(verified: each item appears in the quote below)_
- **Product:** Auvon TENS Massager - Model AS8016 | Nursal TENS and Powered Muscle Stimulator Model AS1080 | Auvon TENS and Powered Muscle Stimulator Model TA3224 | Auvon TENS Massager - Model AS8012 | Auvon TENS Massager - Model AS8016 | Auvon TENS and Powered Muscle Stimulator Model TA3224 | Auvon TENS Massager - Model AS8012 | Auvon TENS Massager - Model AS8016 | Nursal TENS and Powered Muscle Stimulator Model AS1080 _(verified: each item appears in the quote below)_
- **FDA notes:** DWPE Date 06/15/2016 | Class II There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. | Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. | Class II There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. | Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. | DWPE Date 06/15/2016 _(verified: each item appears in the quote below)_

## What the source says

> Shen Zhen As Tec Technology Co Ltd Date Published : 06/15/2016 808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong CHINA 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 11/27/2024 Desc: Auvon TENS Massager - Model AS8016 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 11/18/2024 Desc: Nursal TENS and Powered Muscle Stimulator Model AS1080 Notes: DWPE Date 06/15/2016 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 10/23/2024 Desc: Auvon TENS and Powered Muscle Stimulator Model TA3224 Notes: Class II There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 10/23/2024 Desc: Auvon TENS Massager - Model AS8012 Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/27/2024 Desc: Auvon TENS Massager - Model AS8016 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/23/2024 Desc: Auvon TENS and Powered Muscle Stimulator Model TA3224 Notes: Class II There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/23/2024 Desc: Auvon TENS Massager - Model AS8012 Notes: Class II; There is no information to demonstrate that the devices have the necessary pre-market notification submissions cleared by FDA in order to go to market. 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 11/27/2024 Desc: Auvon TENS Massager - Model AS8016 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 11/18/2024 Desc: Nursal TENS and Powered Muscle Stimulator Model AS1080 Notes: DWPE Date 06/15/2016

## The same source also states

> Shen Zhen As Tec Technology Co Ltd Date Published : 07/21/2025 808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## 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/).