Fuangzhou Balstar Machinery Co · 89-08 · CHINA
For Fuangzhou Balstar Machinery Co · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html