Won Industry Co. LTD · 89-08 · KOREA (THE REPUBLIC OF)
For Won Industry 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 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 2026-09-30.
- Firm
- Won Industry 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
- Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 12/15/2016 verified
- Product code
- 89 I - - RP Massager, Powered Inflatable Tube verified
- Product
- Morning Life Compression Limb Therapy System verified
- FDA notes
- Class II device without a valid 510k verified
What the source says
Won Industry Co. LTD Date Published : 12/15/2016 Wonsaneop , 7-12 Bangadari-Gil , Siheung, Gyeonggi 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html