FDA-Device2017-11-08Class II
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Bios S.r.l.
Hazard
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Sold states
AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV Brazil, Canada, Israel, Japan, & Thailand.
Affected count
167 units
Manufactured in
Via Guido Rossa 10/12, N/A, Vimodrone, N/A, Italy
Products
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2018Don't want to check this manually?
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