# Fuangzhou Balstar Machinery Co · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Bldg Guangdong Shop T4163b 4fl A , Tianjian, CHINA _(verified: appears in the quote below)_
- **Date published:** 11/28/2011 _(verified: appears in the quote below)_
- **Product code:** 79 N - - ZF Massager, cosmetic, static electricity-emitting | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **FDA notes:** Class II/III | class II/III | Class II/III _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).