Reference Source

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

For Guangzhou Konmison Electronic Technology Co., Limited · 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 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 2026-09-16.

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 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:

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

Source

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