Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029922

FEI Number

3001452666

Entity Name

CONTROLTEK, INC.

City/State/Country

Vancouver, WA, US

Establishment Address

3905 NE 112TH AVE., Vancouver, WA 98682, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CONTROLTEK, INC. (Owner Number: 9023255)

Owner / Operator Contact Address

3905 NE 112TH AVE., --, Vancouver, WA 98682, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IOPI System Wrist Actigraph

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKE	Transducer, Miniature Pressure	Physical Medicine	Class 1	890.1615	2012-12-27
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2014-12-08

Official Correspondent

Janine Holder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CONTROLTEK, INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

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3003477135	QUALITY TECH SERVICES, LLC	Bloomington, MN, US
1321175	BATES INDUSTRIES	S Glens Falls, NY, US
3044827682	AVERTTO MEDICAL LTD.	Aderet Jerusalem, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029922. Last updated year: 2026. Please use registration number 3029922 when referencing this establishment in official correspondence.