Guangzhou Health And Medical Equipment Co Ltd · 89-08 · CHINA
For Guangzhou Health And Medical Equipment 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html