Won Industry Co. LTD · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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) 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
— 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.