QJQClass II

Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety

Neurology · 21 CFR 882.5800

To provide electrical current to the head to treat insomnia and/or anxiety

MDR events39All time

Recalls1All time

Registered firms16Currently listed

510(k) clearances19All time

Recent MDR events

39 adverse event reports on file

FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00008
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00009
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00012
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00010
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00011
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00024
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryNanjing Watt Electric Motor Co. Ltd.,3006258094-2023-00007
FW100May 3, 2023
InjuryFisher Wallace Laboratories Inc3006258094-2023-00001
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00027
FISHER WALLACE CRANIAL NEUROSTIMULATORMay 3, 2023
InjuryFisher Wallace Labs3006258094-2023-00025

Event type breakdown

Injury32

Malfunction7

Most-reported manufacturers

Fisher Wallace Labs36 Fisher Wallace Laboratories Inc1 Fisher Wallace Labs.1 Nanjing Watt Electric Motor Co. Ltd.,1

Recalls

1 recall events for this product code

Fisher Wallace Laboratories Inc.
Open, ClassifiedMay 17, 2023
Fisher Wallace Stimulator Models FW-100 and FW-200
If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.
Z-1600-2023 · View FDA record ↗

Registered firms

16 firms currently registered for this product code

510(k) clearances

19 clearances for this product code