Healy: FDA-Cleared Class II Documentation

Happily, Healy is FDA-Cleared

The Food and Drug Administration (FDA) is part of the Federal Government’s Department of Health and Human Services

Healy is FDA-Cleared Class II medical device. This is the "sensor" which transfers info from you to the Healy programs and back. Healy Program Apps FDA-cleared. They work with the Healy sensor to transmit what you need.

For all the details about the wonderful Healy products, Click Here. The purpose of this page is simply to provide evidence regarding the uses for which the FDA has cleared Healy products. Below is a copy of the initial ‘Healy is FDA-Cleared’ letter. Of course, clearance must be renewed periodically.

You don’t need to read the whole thing. Here is the part you probably want to know.

Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
K191075
Device Name
Healy

Indications for Use (Describe)

The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Click to access K191075-FDA-application.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Woman grasping file coming from computer screenThat’s the documentation. Again, for details about how the FDA-Cleared Healy works for pain, go to my main page where I describe things in excruciating detail!  You also may contact me to schedule a demonstration. Email at GetWellStayWell@Outlook.com and put “Request Healy Demo” in the subject line, so that you can rise to the top of a long list of priorities and people!


Here’s wishing us all a pain-free, active, and wonderful life!


Let’s Get Well, Stay Well, and Live Well!