Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030198312

FEI Number

3030198312

Entity Name

ECLOSION

City/State/Country

Fairlawn, OH, US

Establishment Address

1029 Jonathan Ave., Fairlawn, OH 44333, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Eclosion (Owner Number: 10089589)

Owner / Operator Contact Address

1029 Jonathan Ave., Fairlawn, OH 44333, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K892114

PMA Number

N/A

All Registered Proprietary Names

EPX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2023-12-20

Official Correspondent

Rob Ngungu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eclosion

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 3030198312. Last updated year: 2026. Please use registration number 3030198312 when referencing this establishment in official correspondence.