# Pioway Medical Lab Equipment Co. Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Pioway Medical Lab Equipment 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 Ultrasound Scanner | Digital Ultrasound Scanner; product code is 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic; date published is 03/10/2014; address is Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Pioway Medical Lab Equipment 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:** Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 03/10/2014 _(verified: appears in the quote below)_
- **Product code:** 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic _(verified: each item appears in the quote below)_
- **Product:** Digital Ultrasound Scanner | Digital Ultrasound Scanner _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Pioway Medical Lab Equipment Co. Ltd. Date Published : 03/10/2014 Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA 90 I - - TX Transducer, Ultrasonic, Diagnostic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner Notes: Class II 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner 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/).