Healy: FDA Class II Device Documentation

Happily, Healy is Cleared by the FDA

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 Healy Program Apps FDA cleared

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. Below is a copy of the initial 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