Reference Source

Shen Zhen As Tec Technology Co Ltd · 89-08 · CHINA

For Shen Zhen As Tec 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 Auvon TENS Massager - Model AS8012 | 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 | Nursal TENS and Powered Muscle Stimulator Model AS1080 | Auvon TENS Massager - Model AS8016; 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 listed twice: 06/15/2016 and 07/21/2025; address is 808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.

Firm
Shen Zhen As Tec 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
808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing , Shenzhen, Guangdong CHINA verified
Date published
06/15/2016 verified
07/21/2025 also listed
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 each item verified
Product
Auvon TENS Massager - Model AS8012 | 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 | Nursal TENS and Powered Muscle Stimulator Model AS1080 | Auvon TENS Massager - Model AS8016 each item verified
FDA 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. | 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. | DWPE Date 06/15/2016 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— 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 - - 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. 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. 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 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 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 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 11/27/2024 Desc: Auvon TENS Massager - Model AS8016

— all from accessdata.fda.gov, retrieved 2026-09-22

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

— accessdata.fda.gov, retrieved 2026-09-22

Product code

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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.

More on food, drink and consumer products

All 26 datasets on this subject · Look something up