FDA-Device2020-06-03Class II
GENTLEWAVE REF: FG-002-0001
Sonendo Inc
Hazard
The console would continue to run for extended period when the foot pedal was released.
Sold states
U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.
Affected count
460 foot pedals
Manufactured in
26051 Merit Cir Ste 104, N/A, Laguna Hills, CA, United States
Products
GENTLEWAVE REF: FG-002-0001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2020Don't want to check this manually?
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