Cranial Electrotherapy Stimulator To Treat Depression
Neurology · 21 CFR 882.5800
Recent MDR events
21 adverse event reports on file
- FISHER WALLACE STIMULATORAug 14, 2020InjuryFisher-wallace Laboratories, Inc.MW5096089
- FISHER WALLACE STIMULATORSep 15, 2016InjuryFisher Wallace LaboratoriesMW5064789
- FISHER WALLACE STIMULATOROct 7, 2015InjuryFisher Wallace LaboratoriesMW5056926
- FISHER WALLACE STIMULATOR 2 MAOct 7, 2015InjuryFisher Wallace LaboratoriesMW5056948
- ELEXOMA MEDICApr 5, 2015InjuryMW5042001
- FISHER WALLACE BRAIN STIMULATORFeb 16, 2015DeathFisher WallaceMW5040804
- STIMULATOROct 26, 2014InjuryMW5038867
- ALPHA-STIM TECHNOLOGYDec 19, 2013InjuryEpi, IncMW5033542
- SETROX S 45Feb 19, 2013InjuryBiotronik Se & Co. Kg1028232-2013-00448
- ESTELLA DRFeb 19, 2013InjuryBiotronik Se & Co. Kg1028232-2013-00446
Event type breakdown
Recalls
3 recall events for this product code
- Neuro-Fitness LLCTerminatedApr 8, 2008
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fa
No FDA clearance for the .35Hz/.45Hz frequency option on device.
Z-0712-2008 · View FDA record ↗ - Health Directions, IncTerminatedSep 26, 2007
HealthPax Cranial Electrotherapy Stimulator
Peak voltage test result not in acceptable limits.
Z-1242-2007 · View FDA record ↗ - Health Directions, IncTerminatedOct 14, 2004
HealthPax (HP-1). Cranial Electrotherapy Stimulator
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
Z-0019-05 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
2 premarket approvals for this product code