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TruDenta Earclip Electrode Pad
Electromedical Products International, Inc. · Model TruDenta Earclip Electrode Pad · UDI-DI 00857869005239
0
510(k) clearances
21
Adverse events (1 deaths)
3
Recalls
5
Facilities
Description
TruDenta Earclip Electrode Pad
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-10-29 | Neuro-Fitness LLC | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
| 2007-07-19 | Health Directions, Inc | Peak voltage test result not in acceptable limits. |
| 2004-04-08 | Health Directions, Inc | Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device |
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