Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034089185

FEI Number

3034089185

Entity Name

NeckCare Enterprises, Inc

City/State/Country

Minneapolis, MN, US

Establishment Address

520 Nicollet Mall Ste 710, Minneapolis, MN 55402, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NeckCare Holding (Owner Number: 10084645)

Owner / Operator Contact Address

Urdarhvarf 8, Kopavogur, IS-46 203, IS

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NeckCare System NeckCare Exercises NeckCare Home

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2022-03-16
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	Class 2	890.5360	2025-05-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeckCare Holding

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3022115591	NECKCARE	Kopavogur, IS

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034089185. Last updated year: 2026. Please use registration number 3034089185 when referencing this establishment in official correspondence.