Reference Source

Hongkong Phenitech Co Ltd · 89-08 · CHINA

For Hongkong Phenitech 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 Digital Therapy Machine Tens Unit; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 04/07/2013; address is NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA, verified against its source on 2026-09-30.

Firm
Hongkong Phenitech 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
NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA verified
Date published
04/07/2013 verified
Product code
89 I - - SA Massager, Therapeutic, Electric 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

Hongkong Phenitech Co Ltd Date Published : 04/07/2013 NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA

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

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

89 I - - SA Massager, Therapeutic, Electric Date Published: 04/07/2013 Desc: Digital Therapy Machine Tens Unit Notes: Class II

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

Source

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

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