Important Information About Your Fisher Wallace Device (FW-200)

Fisher Wallace Laboratories, Inc.

March 23rd 2023

URGENT: MEDICAL DEVICE CORRECTION

Fisher Wallace Stimulator

Model #: FW-200

Dear Device User,

The purpose of this letter is to advise you that Fisher Wallace Laboratories, Inc. (“Fisher Wallace”) is voluntarily correcting the labeling associated the Fisher Wallace Stimulator, Model #: FW-200, due to product safety concerns. The product may overheat under certain circumstances (see below) which may lead to pain, discomfort, burns or irritation during use of the device.

A review of our records indicate you have received from Fisher Wallace the Fisher Wallace Stimulatory model FW-200. The device model/type may be identified by reviewing the device’s back label field titled “Model:” where the specific model (e.g., FW-200) of Fisher Wallace Laboratories, Inc product is described. Affected serial numbers include serial numbers 2021140129T-2022030528T. The serial number can be found on the device’s back label field titled serial number.

Fisher Wallace was made aware of thirteen (13) complaints between April 2022 to present, related to excess heat of the Fisher Wallace Stimulator battery cover. Two (2) of the thirteen (13) complaints included a complaint of a burn injuries that did not require medical intervention.

Risk to Health:

To avoid potential excess heat of the Fisher Wallace Stimulator FW-200, users are instructed to ensure that the AA batteries are loaded in the correct orientation consistent with the diagram located in the battery compartment. Failure to insert the battery in the correct orientation may cause the device to overheat which may cause potential health risks, such as pain, discomfort, burn or irritation.

Example Notification:

How to recognize that the device may fail?

If the Fisher Wallace Stimulator FW-200 exhibits excess heat, the user is instructed to turn off the device, wait until the device cools, and check the battery compartment for any sign of visual damage, such as but not limited to burning smell or discoloration. If this occurs the user is instructed to please contact Fisher Wallace Laboratories.

The user may also identify this issue if the device exhibits the following behaviors:

• • Failure of the device LED lights to illuminate.
• • Failure of the device to power up to its initial standby mode (i.e., lack of green light).

Actions to be taken by the User:

Short Term Actions

1. Always ensure the batteries are inserted in the device in the correct orientation to reduce the risk of excess heat of the device.

2. Do not leave batteries in the device for any period of time when the device is not in use (e.g. overnight or in between a morning and evening treatment).

3. If the device exhibits excess heat, burning smell or odor, turn off the device and discontinue use. Contact Fisher Wallace Laboratories immediately.

You may choose to dispose of the device. If you do so, please remove the AA batteries, and ensure disposal complies with any/all applicable local, state and federal regulations Long term corrective action is estimated to be complete in Q4 of 2023.

Product and Distribution Information:

The table below outlines the impacted devices.

This voluntary correction is being made with knowledge of the Food and Drug Administration.

Adverse reactions or quality problems experienced with the use of this device may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Fisher Wallace apologizes for the inconvenience. If you have any questions about what to do with the product in your possession please contact Fisher Wallace Laboratories, Inc by telephone Monday through Friday, 10:00 AM to 6:00 PM, Eastern Time at (800) 692-4380 or by email at postmarketsurveillance@fisherwallace.com.

Kelly Roman, Chief Executive Officer