Reference Source

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

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
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
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 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 each item verified
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 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 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

— accessdata.fda.gov, retrieved 2026-09-15

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

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