SONIC WORLD CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For SONIC WORLD 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 Sonix Whole Body Vibration Machines; product code is 89 B - - XB Exerciser, Powered; date published is 11/20/2015; address is 131 Donghwagongdan-ro , Wonju-si, Gangwon-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- SONIC WORLD 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
- 131 Donghwagongdan-ro , Wonju-si, Gangwon-do KOREA (THE REPUBLIC OF) verified
- Date published
- 11/20/2015 verified
- Product code
- 89 B - - XB Exerciser, Powered verified
- Product
- Sonix Whole Body Vibration Machines verified
- FDA notes
- Models VM-10, VH-11, and VC-12. Labels and labeling may bear the address of: 1- 125, Wonju Medical Industry Techno Park, 1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea. verified
What the source says
SONIC WORLD CO., LTD. Date Published : 11/20/2015 131 Donghwagongdan-ro , Wonju-si, Gangwon-do 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 B - - XB Exerciser, Powered Date Published: 11/20/2015 Desc: Sonix Whole Body Vibration Machines Notes: Models VM-10, VH-11, and VC-12. Labels and labeling may bear the address of: 1- 125, Wonju Medical Industry Techno Park, 1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html