# Saeik Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 156-8, Chuneui-Dong, Wonmi-Ku , Wonmi-Ku , Bucheon City, Gyeonggi-Do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/10/2011 _(verified: appears in the quote below)_
- **Product code:** 84 H - - CC Device, Biofeedback _(verified: appears in the quote below)_
- **Product:** eLIFE Electric Field Health Instrument _(verified: appears in the quote below)_
- **FDA notes:** Class; II _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).