Guangzhou Zhuoxin Biological Engineering Co., Ltd · 89-08 · CHINA
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
- 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
- F 1-3 , # 128 East Ring Rd; Pan Yu District , Guangzhou, Guangdong CHINA verified
- Date published
- 03/24/2011 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual each item verified
- Product
- Manual Therapeutic Massager | Manual Therapeutic Massager each item verified
- FDA notes
- Class III verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.