ABATON IND · 89-08 · KOREA (THE REPUBLIC OF)
For ABATON IND, 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 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 2026-09-30.
- 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)
— 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html