THERANICA BIOELECTRONICS LTD

FDA Regulatory Profile

THERANICA BIOELECTRONICS LTD appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2855-2026, Class II) was initiated on March 23, 2026. Its most recent 510(k) clearance was granted on November 8, 2023.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Known Names

theranica bio-electronics, theranica bioelectronics

Recent Recalls

NumberClassProductDate
Z-2855-2026Class IINerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App versiMarch 23, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K232152NerivioInfinityNovember 8, 2023
K223169NerivioFebruary 6, 2023
K203181Nerivio, FGD000075-4.7January 22, 2021
DEN180059Nerivio MigraMay 20, 2019