Guangzhou Health And Medical Equipment Co Ltd · 89-08 · CHINA
For Guangzhou Health And Medical Equipment 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 Electrostatic Field Therapy Device | Electrostatic Field Therapy Device | Electrostatic Field Therapy Device; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 89 I - - SA Massager, Therapeutic, Electric; date published is 10/17/2013; address is 1000 Xin Gang East Rd , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Guangzhou Health And Medical Equipment 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
- 1000 Xin Gang East Rd , Guangzhou, Guangdong CHINA verified
- Date published
- 10/17/2013 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Electrostatic Field Therapy Device | Electrostatic Field Therapy Device | Electrostatic Field Therapy Device each item verified
- FDA notes
- Class II | Class II | Class II each item verified
What the source says
Guangzhou Health And Medical Equipment Co Ltd Date Published : 10/17/2013 1000 Xin Gang East Rd , 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
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 10/17/2013 Desc: Electrostatic Field Therapy Device Notes: Class II 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis Date Published: 10/17/2013 Desc: Electrostatic Field Therapy Device Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 10/17/2013 Desc: Electrostatic Field Therapy Device Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html