Fuangzhou Balstar Machinery Co · 89-08 · CHINA
For Fuangzhou Balstar Machinery Co, 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 Portable High Frequency Spot Remover; JX-006A Massager | Portable High Frequency Spot Remover; JX-006A Massager | Portable High Frequency Spot Remover; JX-006A Massager; product code is 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual; date published is 11/28/2011; address is Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA, verified against its source on 2026-09-30.
- Firm
- Fuangzhou Balstar Machinery Co 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
- Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA verified
- Date published
- 11/28/2011 verified
- Product code
- 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual each item verified
- Product
- Portable High Frequency Spot Remover; JX-006A Massager | Portable High Frequency Spot Remover; JX-006A Massager | Portable High Frequency Spot Remover; JX-006A Massager each item verified
- FDA notes
- Class II/III | class II/III | Class II/III each item verified
What the source says
Fuangzhou Balstar Machinery Co Date Published : 11/28/2011 Bldg Guangdong Shop T4163b 4fl A , Tianjian, 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: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/28/2011 Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: class II/III 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/28/2011 Desc: Portable High Frequency Spot Remover; JX-006A Massager Notes: Class II/III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html