WEIFANG KM ELECTRONICS CO., LTD · 89-08 · CHINA
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
- 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
- No. 7999 Health East Street , High-Tech District , Weifang, Shandong CHINA verified
- Date published
- 11/02/2011 verified
- 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 each item verified
- Product
- Ultrasonic Cavitation Devices | Ultrasonic Cavitation Devices | Ultrasound Beauty Machine | Massager | Massager | Ultrasonic Cavitation Devices | Massager each item verified
- FDA notes
- class II | class II | Class II; 11/02/2011 | Class II; 3/8/2013 | Class II | Class II | class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html