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FDA PRODUCT CODE · CLASS II

QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5899
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
ImplantLife-sustainingGMP-exemptThird-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K250405Theranica Bio-Electronics, Ltd. · 510k2025-05-14
K241756Theranica Bio-Electronics, Ltd. · 510k2024-10-08

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

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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