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FDA PRODUCT CODE · CLASS III
JXK — Cranial Electrotherapy Stimulator To Treat Depression
DEVICE CLASS
Class III
REGULATION
21 CFR 882.5800
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES
Recent clearances
P230024Flow Neuroscience AB · pma2026-07-14
P250010Neurolief , Ltd. · pma2025-12-31
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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