Reference Source

Shenyang Xinzhen Medical Electronic Instrument Company · 89-08 · CHINA

For Shenyang Xinzhen Medical Electronic Instrument Company, 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 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 2026-09-30.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shenyang Xinzhen Medical Electronic Instrument Company Date Published : 09/16/2009 NO. 52 Huanghebeidajie , Huanggu , Chenyang, Liaoning 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

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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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