# Guangzhou Zhuoxin Biological Engineering Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Zhuoxin Biological Engineering 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 Manual Therapeutic Massager | Manual Therapeutic Massager; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual; date published is 03/24/2011; address is F 1-3 , # 128 East Ring Rd; Pan Yu District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Zhuoxin Biological Engineering 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:** F 1-3 , # 128 East Ring Rd; Pan Yu District , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 03/24/2011 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **Product:** Manual Therapeutic Massager | Manual Therapeutic Massager _(verified: each item appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Guangzhou Zhuoxin Biological Engineering Co., Ltd Date Published : 03/24/2011 F 1-3 , # 128 East Ring Rd; Pan Yu District , Guangzhou, Guangdong CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/24/2011 Desc: Manual Therapeutic Massager 89 L - - YG Massager, Therapeutic, Manual Date Published: 03/24/2011 Desc: Manual Therapeutic Massager Notes: Class III

## 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/).