Race Beauty Equipment Co., Ltd. · 89-08 · CHINA
For Race Beauty Equipment Co., Ltd., 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 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 2026-09-30.
- 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
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
— 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 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html