Reference Source

Guangzhou Konmison Electronic Technology Co., Limited · 89-08 · CHINA

For Guangzhou Konmison Electronic Technology Co., Limited, 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 Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager; product code is 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - LI Fat Reducing Low Level Laser | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 P - - BX Massager, vacuum, radio frequency induced heat | 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use | 89 P - - HW Cold pack and vibrating massager; date published is 02/21/2018; address is Guangyi Business Center E-202 , Baiyun Avenue North 86 Baiyun , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.

Firm
Guangzhou Konmison Electronic Technology Co., Limited 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
Guangyi Business Center E-202 , Baiyun Avenue North 86 Baiyun , Guangzhou, Guangdong CHINA verified
Date published
02/21/2018 verified
Product code
79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - LI Fat Reducing Low Level Laser | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 P - - BX Massager, vacuum, radio frequency induced heat | 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use | 89 P - - HW Cold pack and vibrating massager each item verified
Product
Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager | Cold Pack and Vibrating Massager 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

Guangzhou Konmison Electronic Technology Co., Limited Date Published : 02/21/2018 Guangyi Business Center E-202 , Baiyun Avenue North 86 Baiyun , Guangzhou, Guangdong CHINA

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

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 and Product

79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes: 79 O - - LI Fat Reducing Low Level Laser Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes: 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes: 79 P - - BX Massager, vacuum, radio frequency induced heat Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes: 79 P - - KT Laser for disruption of adipocyte cells for aesthetic use Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes: 89 P - - HW Cold pack and vibrating massager Date Published: 02/21/2018 Desc: Cold Pack and Vibrating Massager Notes:

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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