Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029924306

FEI Number

3029924306

Entity Name

GRAYMATTERS HEALTH

City/State/Country

Haifa, IL

Establishment Address

Haazmaut 82, Haifa 340072, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GrayMatters Health (Owner Number: 10089026)

Owner / Operator Contact Address

Haazmaut 82, Haifa, IL-HA 340072, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222101

PMA Number

N/A

All Registered Proprietary Names

Prism

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2023-10-30

Official Correspondent

Oded Kraft

US Agent Details

Kirk Thelander Business: Kirk Thelander Email: Kirk@graymatters-health.com Phone: (484) 5351484

Related Public Records

Same Entity

GrayMatters Health

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029924306. Last updated year: 2026. Please use registration number 3029924306 when referencing this establishment in official correspondence.