SONIC WORLD CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For SONIC WORLD 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 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 2026-09-16.
- 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) 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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