510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203181Substantially Equivalent

Nerivio, FGD000075-4.7

Theranica Bio-Electronics Ltd., Netanya, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203181 is the FDA 510(k) clearance record for Nerivio, FGD000075-4.7, a class II device, cleared for Theranica Bioelectronics , Ltd. on under FDA product code QGT (Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine). FDA's definition for product code QGT reads: "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...". FDA records list 7 510(k) clearances for THERANICA BIO-ELECTRONICS LTD., from to . As of , FDA records show no recalls naming K203181.

Clearance record

Decision date
Received
(88 days to decision)
Product code
QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Regulation
21 CFR 882.5899
Device class
Class II
Review panel
Neurology
Applicant
Theranica Bioelectronics , Ltd. 4 Ha-Omanut St. Poleg Industrial Park, Netanya, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QGT

Trailing 12 months

FDA records hold no clearances under product code QGT in the trailing twelve months.

FDA records show no clearances under product code QGT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QGT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260