Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. · 89-08 · CHINA
For Guangzhou Hua Nan Medical Apparatus & Instruments 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 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 2026-09-30.
- Firm
- Guangzhou Hua Nan Medical Apparatus & Instruments 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
- 212 Xingang W. Road , Guangzhou, CHINA verified
- Date published
- 01/23/2019 verified
- Product code
- 89 - - - -- Physical Medicine verified
- Product
- Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices verified
- FDA notes
- 2/24/1998 verified
What the source says
Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. Date Published : 01/23/2019 212 Xingang W. Road , Guangzhou, 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 - - - -- Physical Medicine Date Published: 01/23/2019 Desc: Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices Notes: 2/24/1998
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html