Saeik Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Saeik 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 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 2026-09-30.
- 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)
— 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 H - - CC Device, Biofeedback Date Published: 08/10/2011 Desc: eLIFE Electric Field Health Instrument Notes: Class; II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html