Saeik Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Saeik 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 is eLIFE Electric Field Health Instrument; product code is 84 H - - CC Device, Biofeedback; date published is 08/10/2011; address is 156-8, Chuneui-Dong, Wonmi-Ku , Wonmi-Ku , Bucheon City, Gyeonggi-Do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Saeik 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
- 156-8, Chuneui-Dong, Wonmi-Ku , Wonmi-Ku , Bucheon City, Gyeonggi-Do KOREA (THE REPUBLIC OF) verified
- Date published
- 08/10/2011 verified
- Product code
- 84 H - - CC Device, Biofeedback verified
- Product
- eLIFE Electric Field Health Instrument verified
- FDA notes
- Class; II verified
What the source says
Saeik Medical Co., Ltd. Date Published : 08/10/2011 156-8, Chuneui-Dong, Wonmi-Ku , Wonmi-Ku , Bucheon City, Gyeonggi-Do KOREA (THE REPUBLIC OF) 84 H - - CC Device, Biofeedback Date Published: 08/10/2011 Desc: eLIFE Electric Field Health Instrument Notes: Class; II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.