# Guangzhou Health And Medical Equipment Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 1000 Xin Gang East Rd , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 10/17/2013 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Electrostatic Field Therapy Device | Electrostatic Field Therapy Device | Electrostatic Field Therapy Device _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).