WEIFANG KM ELECTRONICS CO., LTD · 89-08 · CHINA
For WEIFANG KM ELECTRONICS CO., LTD, import alert is 89-08; country is CHINA; 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)"; product is Ultrasonic Cavitation Devices | Ultrasonic Cavitation Devices | Massager | Ultrasound Beauty Machine | 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 2026-09-30.
- 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 | Massager | Ultrasound Beauty Machine | Massager | Ultrasonic Cavitation Devices | Massager each item verified
- FDA notes
- class II | class II | Class II; 3/8/2013 | Class II; 11/02/2011 | 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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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: Massager Notes: Class II; 3/8/2013 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 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html