Reference Source

SHANDONG HUAMEI TECHNOLOGY CO.,LTD. · 89-08 · CHINA

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
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
588 Changning Street , High-Tech District , Weifang, Shandong CHINA verified
Date published
08/24/2021 verified
Product code
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Cavitation and Radio Frequency Slimming Machine HM-800 | Cavitation and Radio Frequency Slimming Machine HM-800 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.