FDA Warns of Misleading and False Advertising by Ease Cushion
FDA warns of misleading and false advertising from companies like Ease cushion
You may have seen advertising from websites selling medical devices in the United States, sometimes accompanied by an FDA logo:
- FDA Registered
- FDA Certified
- FDA Registration Certificate
Such words may be used to mislead you. Do these words mean FDA approved, FDA cleared, or FDA authorized? The short answer is no. Here’s why…
Those who own or operate a place of business (establishment, or facility) are generally required to register with the FDA annually if they are involved with the production and/or distribution of medical devices.
It’s important to understand:
“When a facility registers and lists its devices, the resulting entry in FDA’s registration and listing database does not denote approval, clearance or authorization of that facility or its medical devices” (FDA, 2021).
The Ease cushion website contains the following statement:
“Registered with the FDA for the treatment and prevention of bedsores or decubitus ulcers.”
This is a false and misleading statement because the FDA does not “register” a product for any specific treatment or function. Regarding class one medical devices, the FDA involvement is limited to the collecting of registration fees from the facilities or establishments producing and/or distributing the medical device.
The Ease cushion was not examined or cleared for use by anyone from the FDA. The FDA does not condone or approve of the Ease cushion for having anything whatsoever to do with the prevention or treatment of decubitus ulcers. Ease cushion uses this directly misleading statement in a desperate move to get sales from vulnerable consumers who were tricked by the deceptive statement on their website.
The Ease cushion is classified as a cookie cutter alternating wheelchair cushion. Like all the other off-the-shelf alternating wheelchair cushions, every single one is made the same and with no consideration for the client’s current pressure sores or sensitive areas. This means, like all the other non-customized alternating wheelchair cushions, the Ease cushion will apply a great deal of pressure back and forth to all areas of your posterior – including directly to an existing sore. That’s the worst thing you can do for a current sore and that is how pressure sores degrade and get worse. If anything, cushions like the Ease cushion may be detrimental to pressure sore health.
Like all the other cookie cutter wheelchair cushions, Ease cushions have no clinical evidence, clinical studies, or case studies validating their advertisement claims.
If you want an effective and proven alternating wheelchair cushions, the Aquila wheelchair cushion is the only Wheelchair Cushion designed to prevent and heal pressure injuries. The Aquila Airpulse PK2 and Aquila SofTech wheelchair cushions are designed to automatically alternate pressure every 60 seconds. Our patented design utilizes alternating therapy to eliminate the number one cause of pressure sores – constant pressure. Aquila alternating wheelchair cushions are much smarter and an infinitely easier method to ensure pressure relief 60 times per hour. Contact Aquila for more information today.