Reference Source

Foshan Nanhai Donghui · 89-08 · CHINA

For Foshan Nanhai Donghui · 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 Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep; date published is 04/05/2013; address is Rm A 18/F Development Bldeast Huayuan , Foshan, CHINA, verified against its source on 2026-09-16.

Firm
Foshan Nanhai Donghui 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
Rm A 18/F Development Bldeast Huayuan , Foshan, CHINA verified
Date published
04/05/2013 verified
Product code
79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep each item verified
Product
Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine | Facial Beauty Machine each item verified
FDA notes
Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 | Class II, DWPE Date 4/5/2013 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

Foshan Nanhai Donghui Date Published : 04/05/2013 Rm A 18/F Development Bldeast Huayuan , Foshan, CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 G - - FE Brush, Dermabrasion Date Published: 04/05/2013 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 01/23/2019 Desc: Facial Beauty Machine Notes: Class II, DWPE Date 4/5/2013

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

Source

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