Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023531666

FEI Number

3023531666

Entity Name

Nextern Costa Rica Ltd.

City/State/Country

Cartago, CR

Establishment Address

Multitenant 2 Modulo 4., Cartago 30106, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nextern Innovation, Inc (Owner Number: 10037078)

Owner / Operator Contact Address

10601 Fountains Drive, Maple Grove, MN 55369, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

THE INCOURAGE SYSTEM SPRINT Peripheral Nerve Stimulation (PNS) System Enterra II Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2022-06-14
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Neurology	Class 2	882.5890	2023-01-31
LNQ	Intestinal Stimulator	Unknown	Class f	N/A	2025-12-12

Official Correspondent

Caroline Byrd

US Agent Details

Caroline Byrd Business: NEXTERN INNOVATION, INC Email: regulatory@nextern.com Phone: (651) 2032100

Related Public Records

Same Entity

Nextern Innovation, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016908271	Nextern Vietnam LLC	Ben Cat District Binh Duong, VN
3031976597	Nextern	Maple Grove, MN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023531666. Last updated year: 2026. Please use registration number 3023531666 when referencing this establishment in official correspondence.