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

For WEIFANG KM ELECTRONICS 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 Ultrasonic Cavitation Devices | Ultrasonic Cavitation Devices | Ultrasound Beauty Machine | Massager | Massager | Ultrasonic Cavitation Devices | Massager; product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 P - - BX Massager, vacuum, radio frequency induced heat | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - YG Massager, Therapeutic, Manual; date published is 11/02/2011; address is No. 7999 Health East Street , High-Tech District , Weifang, Shandong CHINA, verified against its source on 2026-09-16.

- **Firm:** WEIFANG KM ELECTRONICS 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:** No. 7999 Health East Street , High-Tech District , Weifang, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 11/02/2011 _(verified: appears in the quote below)_
- **Product code:** 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 P - - BX Massager, vacuum, radio frequency induced heat | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **Product:** Ultrasonic Cavitation Devices | Ultrasonic Cavitation Devices | Ultrasound Beauty Machine | Massager | Massager | Ultrasonic Cavitation Devices | Massager _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | Class II; 11/02/2011 | Class II; 3/8/2013 | Class II | Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> WEIFANG KM ELECTRONICS CO., LTD Date Published : 11/02/2011 No. 7999 Health East Street , High-Tech District , Weifang, Shandong CHINA 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 04/23/2014 Desc: Ultrasonic Cavitation Devices Notes: class II 79 P - - BX Massager, vacuum, radio frequency induced heat Date Published: 04/23/2014 Desc: Ultrasonic Cavitation Devices Notes: class II 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 01/30/2019 Desc: Ultrasound Beauty Machine Notes: Class II; 11/02/2011 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 01/30/2019 Desc: Massager Notes: Class II; 3/8/2013 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/08/2013 Desc: Massager Notes: Class II 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 04/23/2014 Desc: Ultrasonic Cavitation Devices Notes: Class II 89 L - - YG Massager, Therapeutic, Manual Date Published: 03/08/2013 Desc: Massager 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/).