Nuga Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Nuga Medical Co., Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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
What the source says
Nuga Medical Co., Ltd. Date Published : 09/16/2009 185 Jiraeul-Ro , Jijeong-Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF)
— 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 and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html