THERANICA USA

FDA Device Registration & Listing · Bridgewater, NJ, US · Registration 3015549449

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015549449
FEI Number
3015549449
Entity Name
THERANICA USA
City/State/Country
Bridgewater, NJ, US
Establishment Address
100 Somerset Corporate Blvd, 2nd Fl, Ste 160, Bridgewater, NJ 08807, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Theranica USA (Owner Number: 10060939)
Owner / Operator Contact Address
100 Somerset Corporate Blvd., 2nd Fl, Suite 160, Bridgewater, NJ 08807, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K250405
PMA Number
N/A

All Registered Proprietary Names

Nerivio Infinity Nerivio Infinity refill unit Nerivio

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine Neurology Class 2 882.5899 2026-05-05

Official Correspondent

John Avery

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theranica USA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015549449. Last updated year: 2026. Please use registration number 3015549449 when referencing this establishment in official correspondence.
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