Device product
GENTLEWAVE REF: FG-002-0001
Z-2162-2020
Product summary
- Firm
- Sonendo Inc
- Event
- Event 85593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 460 foot pedals
- Official record key
device-enforcement:Z-2162-2020
Official wording
Reason: The console would continue to run for extended period when the foot pedal was released.
Code information: Foot Pedal, P/N: 102-0186-001 of GENTLEWAVE REF: FG-002-0001 device: Lot#: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330
Distribution pattern: 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.
Derived failure modes
-
Unknown
The console would continue to run for extended period when the foot pedal was released.