ABATON IND · 89-08 · KOREA (THE REPUBLIC OF)
For ABATON IND · 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 Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA); product code is 89 I - - LY Lamp, infrared, therapeutic heating; date published is 07/13/2011; address is Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- ABATON IND 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
- Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF) verified
- Date published
- 07/13/2011 verified
- Product code
- 89 I - - LY Lamp, infrared, therapeutic heating verified
- Product
- Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA) verified
- FDA notes
- Class II verified
What the source says
ABATON IND Date Published : 07/13/2011 Seojung-Dong , Pyungtaek City, KOREA (THE REPUBLIC OF) 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/13/2011 Desc: Abaton Far Infrared Massage Bed II Models (800 DX; MS and 800 SA) Notes: Class II
— 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.