# Guangzhou Inkue Technology Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Inkue Technology 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 Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption; date published is 11/01/2012; address is Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Inkue Technology 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:** Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 11/01/2012 _(verified: appears in the quote below)_
- **Product code:** 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption _(verified: each item appears in the quote below)_
- **Product:** Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine | Skin Scrubber Beauty Machine _(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 Inkue Technology Co Ltd Date Published : 11/01/2012 Floor 3 Tower A, Fengsheng Industry , Guangzhou, CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine Notes: class II 79 G - - FE Brush, Dermabrasion Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine Notes: class II 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 11/01/2012 Desc: Skin Scrubber Beauty Machine 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/).