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Panels › Neurology › Product code QGT · Class 2

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Regulation 882.5899

0510(k)s in 12 months (7 all time)
1recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in QGT

Company510(k)sRecalls
Theranica Bioelectronics , Ltd.41
Theranica Bio-Electronics, Ltd.30
Decided510(k)Device and applicantCode
May 14, 2025K250405Nerivio; Nerivio Infinity
Theranica Bio-Electronics, Ltd., IL
QGT
Oct 8, 2024K241756Nerivio; NerivioInfinity
Theranica Bio-Electronics, Ltd., IL
QGT
Nov 8, 2023K232152NerivioInfinity
Theranica Bioelectronics , Ltd., IL
QGT
Feb 6, 2023K223169Nerivio
Theranica Bioelectronics , Ltd., IL
QGT
Jan 22, 2021K203181Nerivio, FGD000075-4.7
Theranica Bioelectronics , Ltd., IL
QGT
Oct 23, 2020K201824Nerivio
Theranica Bio-Electronics, Ltd., IL
QGT
May 20, 2019DEN180059Nerivio Migra
Theranica Bioelectronics , Ltd., IL
QGT

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