# Won Industry Co. LTD · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Won Industry 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 Morning Life Compression Limb Therapy System; product code is 89 I - - RP Massager, Powered Inflatable Tube; date published is 12/15/2016; address is Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Won Industry 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:** Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/15/2016 _(verified: appears in the quote below)_
- **Product code:** 89 I - - RP Massager, Powered Inflatable Tube _(verified: appears in the quote below)_
- **Product:** Morning Life Compression Limb Therapy System _(verified: appears in the quote below)_
- **FDA notes:** Class II device without a valid 510k _(verified: appears in the quote below)_

## What the source says

> Won Industry Co. LTD Date Published : 12/15/2016 Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi KOREA (THE REPUBLIC OF) 89 I - - RP Massager, Powered Inflatable Tube Date Published: 12/15/2016 Desc: Morning Life Compression Limb Therapy System Notes: Class II device without a valid 510k

## 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/).