# GUANGZHOU KONMISON · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GUANGZHOU KONMISON · 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 8D HIFU Home Use Massager; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 04/08/2025; address is Kangmeisen No 1 Wa , Guangzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** GUANGZHOU KONMISON _(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:** Kangmeisen No 1 Wa , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 04/08/2025 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric _(verified: appears in the quote below)_
- **Product:** 8D HIFU Home Use Massager _(verified: appears in the quote below)_

## What the source says

> GUANGZHOU KONMISON Date Published : 04/08/2025 Kangmeisen No 1 Wa , Guangzhou, CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/08/2025 Desc: 8D HIFU Home Use Massager

## 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/).