Shenyang Xinzhen Medical Electronic Instrument Company · 89-08 · CHINA
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
- 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
- NO. 52 Huanghebeidajie , Huanggu , Chenyang, Liaoning CHINA verified
- Date published
- 09/16/2009 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html