Reference Source

Race Beauty Equipment Co., Ltd. · 89-08 · CHINA

For Race Beauty Equipment Co., Ltd. · 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 Biolift Beauty Machine | Biolift Beauty Machine | Biolift Beauty Machine; product code is 79 N - - ZF Massager, cosmetic, static electricity-emitting | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes; date published is 09/14/2012; address is Jiulong Industrial Park , No 23 Fenghuang 4 Rd , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Race Beauty Equipment Co., Ltd. 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
Jiulong Industrial Park , No 23 Fenghuang 4 Rd , Guangzhou, Guangdong CHINA verified
Date published
09/14/2012 verified
Product code
79 N - - ZF Massager, cosmetic, static electricity-emitting | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes each item verified
Product
Biolift Beauty Machine | Biolift Beauty Machine | Biolift Beauty Machine each item verified
FDA notes
class II | 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

Race Beauty Equipment Co., Ltd. Date Published : 09/14/2012 Jiulong Industrial Park , No 23 Fenghuang 4 Rd , Guangzhou, Guangdong CHINA 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Biolift Beauty Machine Notes: class II 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 09/14/2012 Desc: Biolift Beauty Machine Notes: Class II 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 09/14/2012 Desc: Biolift Beauty Machine Notes: class II

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

Source

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