Reference Source

Nuga Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)

For Nuga Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 M - - PH Stimulator, Electrical, Muscle | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 09/16/2009; address is 185 Jiraeul-Ro , Jijeong-Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Nuga Medical Co., Ltd. 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
KOREA (THE REPUBLIC OF) verified
Address
185 Jiraeul-Ro , Jijeong-Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) verified
Date published
09/16/2009 verified
Product code
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 M - - PH Stimulator, Electrical, Muscle | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
FDA notes
Nuga Best NM5000 4/19/2005 | Nuga Best NM5000 4/19/2005 | Nuga Best NM5000 4/19/2005 | Nuga Best NM5000 4/19/2005 | Nuga Best NM5000 4/19/2005 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

Nuga Medical Co., Ltd. Date Published : 09/16/2009 185 Jiraeul-Ro , Jijeong-Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 09/16/2009 Notes: Nuga Best NM5000 4/19/2005 89 I - - PF Stimulator, Muscle, Powered Date Published: 09/16/2009 Notes: Nuga Best NM5000 4/19/2005 89 I - - SA Massager, Therapeutic, Electric Date Published: 09/16/2009 Notes: Nuga Best NM5000 4/19/2005 89 M - - PH Stimulator, Electrical, Muscle Date Published: 09/16/2009 Notes: Nuga Best NM5000 4/19/2005 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 09/16/2009 Notes: Nuga Best NM5000 4/19/2005

accessdata.fda.gov, retrieved 2026-09-15

Source

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