Home › Device types › JXK
Cranial Electrotherapy Stimulator To Treat Depression
FDA product code JXK · Class 3 · Neurology
16
Registered devices
21
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Cervella — INNOVATIVE NEUROLOGICAL DEVICES LLCAlpha-Stim Earclip Electrode Pad — Electromedical Products International, Inc.TruDenta Earclip Electrode Pad — Electromedical Products International, Inc.CES-Ultra — NEURO-FITNESS LLCAlpha-Stim Earclip Electrode (CE3) — Electromedical Products International, Inc.Nexalin — NEXALIN TECHNOLOGYCES-Ultra — NEURO-FITNESS LLCAlpha-Stim Conducting Solution — Electromedical Products International, Inc.Alpha-Stim Earclip Electrode (M) — Electromedical Products International, Inc.Alpha-Stim Earclip Electrode (AID) — Electromedical Products International, Inc.Alpha Conducting Solution — Electromedical Products International, Inc.Nexalin — NEXALIN TECHNOLOGYJohari Digital Healthcare Ltd. — SYRMA JOHARI MEDTECH LIMITEDAlpha-Stim Earclip Electrode (AID) — Electromedical Products International, Inc.Alpha-Stim Conducting Solution — Electromedical Products International, Inc.Alpha Conducting Solution — Electromedical Products International, Inc.
Recent 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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