# Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Hua Nan Medical Apparatus & Instruments 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 Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices; product code is 89 - - - -- Physical Medicine; date published is 01/23/2019; address is 212 Xingang W. Road , Guangzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Hua Nan Medical Apparatus & Instruments 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:** 212 Xingang W. Road , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 01/23/2019 _(verified: appears in the quote below)_
- **Product code:** 89 - - - -- Physical Medicine _(verified: appears in the quote below)_
- **Product:** Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices _(verified: appears in the quote below)_
- **FDA notes:** 2/24/1998 _(verified: appears in the quote below)_

## What the source says

> Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. Date Published : 01/23/2019 212 Xingang W. Road , Guangzhou, CHINA 89 - - - -- Physical Medicine Date Published: 01/23/2019 Desc: Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices Notes: 2/24/1998

## 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/).