# Hongkong Phenitech Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Hongkong Phenitech 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 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 2026-09-16.

- **Firm:** Hongkong Phenitech 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:** NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 04/07/2013 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric _(verified: appears in the quote below)_
- **Product:** Digital Therapy Machine Tens Unit _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Hongkong Phenitech Co Ltd Date Published : 04/07/2013 NO 2709 West Towercoast Kafunuo Bldg No , Shenzhenshenzhen, CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/07/2013 Desc: Digital Therapy Machine Tens Unit Notes: Class II

## 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/).