Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011088301

FEI Number

3011088301

Entity Name

ONDAMED INC.

City/State/Country

WASHINGTONVILLE, NY, US

Establishment Address

5 FAIRLAWN DR STE 200, WASHINGTONVILLE, NY 10992, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ondamed Inc. (Owner Number: 9052444)

Owner / Operator Contact Address

5 Fairlawn Drive, Suite 200, Washingtonville, NY 10992, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ONDAMED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2002-08-06

Official Correspondent

SILVIA BINDER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ondamed Inc.

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 3011088301. Last updated year: 2026. Please use registration number 3011088301 when referencing this establishment in official correspondence.