# SHANDONG HUAMEI TECHNOLOGY CO.,LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHANDONG HUAMEI 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 Cavitation and Radio Frequency Slimming Machine HM-800 | Cavitation and Radio Frequency Slimming Machine HM-800; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - SA Massager, Therapeutic, Electric; date published is 08/24/2021; address is 588 Changning Street , High-Tech District , Weifang, Shandong CHINA, verified against its source on 2026-09-16.

- **Firm:** SHANDONG HUAMEI 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:** 588 Changning Street , High-Tech District , Weifang, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/24/2021 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Cavitation and Radio Frequency Slimming Machine HM-800 | Cavitation and Radio Frequency Slimming Machine HM-800 _(verified: each item appears in the quote below)_

## What the source says

> SHANDONG HUAMEI TECHNOLOGY CO.,LTD. Date Published : 08/24/2021 588 Changning Street , High-Tech District , Weifang, Shandong CHINA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 08/24/2021 Desc: Cavitation and Radio Frequency Slimming Machine HM-800 89 I - - SA Massager, Therapeutic, Electric Date Published: 08/24/2021 Desc: Cavitation and Radio Frequency Slimming Machine HM-800

## 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/).