Reference Source

Shenzhen Dowse Electronics Co Ltd · 89-08 · CHINA

For Shenzhen Dowse Electronics 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 Digital Therapy Machine Tens Unit; product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter; date published is 04/07/2013; address is 5f No5 Bldg Minxing Industrialpark , Shenzhenshenzhen, CHINA, verified against its source on 2026-09-16.

Firm
Shenzhen Dowse Electronics 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
5f No5 Bldg Minxing Industrialpark , Shenzhenshenzhen, CHINA verified
Date published
04/07/2013 verified
Product code
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter verified
Product
Digital Therapy Machine Tens Unit verified
FDA notes
class II verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shenzhen Dowse Electronics Co Ltd Date Published : 04/07/2013 5f No5 Bldg Minxing Industrialpark , Shenzhenshenzhen, CHINA 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 04/07/2013 Desc: Digital Therapy Machine Tens Unit Notes: class II

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

Source

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