Reference Source

Ningbo Ruipu Medical Comfort Equipm · 89-08 · CHINA

For Ningbo Ruipu Medical Comfort Equipm · 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 Radio Frequency Skin Lifting device | Radio Frequency Skin Lifting device; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat; date published is 11/10/2011; address is No. 8 Gulin , Haishu District , Ningbo, Zhejiang CHINA, verified against its source on 2026-09-16.

Firm
Ningbo Ruipu Medical Comfort Equipm 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. 8 Gulin , Haishu District , Ningbo, Zhejiang CHINA verified
Date published
11/10/2011 verified
Product code
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat each item verified
Product
Radio Frequency Skin Lifting device | Radio Frequency Skin Lifting device each item verified
FDA notes
Class II | Class II 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

Ningbo Ruipu Medical Comfort Equipm Date Published : 11/10/2011 No. 8 Gulin , Haishu District , Ningbo, Zhejiang CHINA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 11/10/2011 Desc: Radio Frequency Skin Lifting device Notes: Class II 89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat Date Published: 11/10/2011 Desc: Radio Frequency Skin Lifting device Notes: Class II

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

Source

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