Theranica Bio-Electronics Ltd.

Caesarea Central, IL

THERANICA BIO-ELECTRONICS LTD. appears in FDA device records in Caesarea Central, IL. FDA records list 7 510(k) clearances between 2019-05-20 and 2025-05-14, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 7
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Theranica Bio-Electronics Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Theranica Bioelectronics , Ltd.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 7 510(k) clearances for Theranica Bio-Electronics Ltd. between 2019 and 2025. The busiest year on record is 2023, with 2. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Theranica Bio-Electronics Ltd., by decision year
Year	Clearances
2019	1
2020	1
2021	1
2023	2
2024	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250405	Nerivio; Nerivio Infinity	QGT	Substantially Equivalent	2025-05-14
K241756	Nerivio; NerivioInfinity	QGT	Substantially Equivalent	2024-10-08
K232152	NerivioInfinity	QGT	Substantially Equivalent	2023-11-08
K223169	Nerivio	QGT	Substantially Equivalent	2023-02-06
K203181	Nerivio, FGD000075-4.7	QGT	Substantially Equivalent	2021-01-22
K201824	Nerivio	QGT	Substantially Equivalent	2020-10-23
DEN180059	Nerivio Migra	QGT	Unknown	2019-05-20

Registered establishments

FDA registered establishments for Theranica Bio-Electronics Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015379717	3015379717	THERANICA BIO-ELECTRONICS LTD.	9 Granit st., North Industrial Park, Caesarea Central 3079893 IL	2026	QGT

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2855-2026	Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11	Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.	Class II	2026-03-23	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain