# Shenyang Xinzhen Medical Electronic Instrument Company · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenyang Xinzhen Medical Electronic Instrument Company · 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 BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator; product code is 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - PF Stimulator, Muscle, Powered | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 09/16/2009; address is NO. 52 Huanghebeidajie , Huanggu , Chenyang, Liaoning CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenyang Xinzhen Medical Electronic Instrument Company _(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:** NO. 52 Huanghebeidajie , Huanggu , Chenyang, Liaoning CHINA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - PF Stimulator, Muscle, Powered | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning _(verified: each item appears in the quote below)_
- **Product:** BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator | BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator _(verified: each item appears in the quote below)_
- **FDA notes:** DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 _(verified: each item appears in the quote below)_

## What the source says

> Shenyang Xinzhen Medical Electronic Instrument Company Date Published : 09/16/2009 NO. 52 Huanghebeidajie , Huanggu , Chenyang, Liaoning CHINA 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 08/25/2023 Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/2005 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 08/25/2023 Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/2005 89 I - - PF Stimulator, Muscle, Powered Date Published: 08/25/2023 Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/2005 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 08/25/2023 Desc: BFGF-8 Computer Controlled Weight Reducing Machine Muscle Stimulator Notes: DWPE Date 7/20/2005

## 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/).