Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006258094

FEI Number

3006258094

Entity Name

FISHER WALLACE LABORATORIES Inc

City/State/Country

Brooklyn, NY, US

Establishment Address

630 Flushing Avenue, Suite 104, Brooklyn, NY 11206, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

FISHER-WALLACE LABORATORIES Inc (Owner Number: 9100824)

Owner / Operator Contact Address

630 Flushing Ave, Ste 104, Brooklyn, NY 11206, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K894515

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWM	Device, Electrical Dental Anesthesia	Unknown	Class U	N/A	2010-12-28
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2007-04-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-04-25
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Neurology	Class 2	882.5800	2007-04-25
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Neurology	Class 2	882.5800	2007-04-25

Official Correspondent

Kelly Roman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FISHER-WALLACE LABORATORIES 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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3017463707	Multi-Concept Interconnect Solutions Co., Ltd.	Dongguan City Guangdong, CN
2528981	LYNX Medical Pennsylvania	ERIE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006258094. Last updated year: 2026. Please use registration number 3006258094 when referencing this establishment in official correspondence.