Guangzhou Zhuoxin Biological Engineering Co., Ltd · 89-08 · CHINA
For Guangzhou Zhuoxin Biological Engineering Co., Ltd, import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html