Reference Source

Ningbo Ruipu Medical Comfort Equipm · 89-08 · CHINA

For Ningbo Ruipu Medical Comfort Equipm, 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 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 2026-09-30.

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

— 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, Product and FDA notes

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

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

Source

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