Data / Medical devices / United States / FISHER WALLACE LABORATORIES Inc

FISHER WALLACE LABORATORIES Inc: FDA-registered device maker in Brooklyn, NY, United States, 6 510(k) clearances

Name: FISHER WALLACE LABORATORIES Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

FISHER WALLACE LABORATORIES Inc is registered with the FDA (registration 3006258094) in Brooklyn, NY, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 30, 1992. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006258094
Address: 630 Flushing Avenue Suite 104, Brooklyn, NY, United States, 11206
Owner or operator: FISHER-WALLACE LABORATORIES Inc (9100824)
Roles: Specification developer
First device listed: April 25, 2007
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	QJQ	2	Specification developer	accessdata.fda.gov
Device, Electrical Dental Anesthesia	LWM	U	Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Specification developer	accessdata.fda.gov
Electrode, Depth	GZL	2	Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 30, 1992	K913031	K-STIM	GXY	Substantially Equivalent	Katecho, Inc.	accessdata.fda.gov
December 17, 1990	K900731	MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)	LWM	Substantially Equivalent	Medical Consultants Intl. , Ltd.	accessdata.fda.gov
October 4, 1990	K903654	LISS CRANIAL STIMULATOR MODEL SBL202-B	QJQ	Substantially Equivalent	Medical Consultants Intl. , Ltd.	accessdata.fda.gov
September 7, 1990	K902976	MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC	GZL	Substantially Equivalent	Medical Consultants Intl. , Ltd.	accessdata.fda.gov
May 3, 1990	K894515	LISS CRANIAL STIMULATOR MODEL SBL201-M	QJQ	Substantially Equivalent	Medical Consultants Intl. , Ltd.	accessdata.fda.gov
April 10, 1990	K896226	LISS BODY STIMULATOR MODEL SBL501-M	GZJ	Substantially Equivalent	Medical Consultants Intl. , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 6, 2023	91982	Class II	Ongoing	Fisher Wallace Stimulator Models FW-100 and FW-200	If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.	accessdata.fda.gov

Compare with other makers

Updated May 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.