LifeVac® vs Illegal Counterfeit Devices - Why they are so dangerous?

LifeVac® vs Illegal Counterfeit Devices - Why they are so dangerous?

Are there “no-name” versions of LifeVac that are the same?

What YOU NEED to know before it’s too late!

The simple answer is NO, there aren’t. There is only one genuine, patented, tested, and approved LifeVac® airway clearance device.

Since 2012, when the very first patent was issued to LifeVac®, our mission was to set the bar for all airway clearance devices/choking rescue devices to follow, through regulator approval, testing, research, and quality.

Having now saved over 2700 lives in choking emergencies, including over 1700 children, as well as receiving the backing of multiple peer-reviewed medical publications and independent studies, we have set the bar very high for others to follow. Sadly, this includes those who have no interest in saving lives but just want to make a quick dollar by deceiving the public with a device that looks the same but is not the same.

Each component of a LifeVac® device is quality-checked before and after assembly. The materials used to manufacture LifeVac® have been tested for compatibility, safety, durability, and environmental resistance, and specifically chosen to maintain these high standards.

Genuine LifeVac® devices are manufactured in USA or UK only. Every LifeVac® device that leaves our manufacturing plants is tested to ensure that the device produces the perfect amount of suction, and no air can be forced through the mask when applied.

LifeVac® is a medical device registered and regulated by governing bodies in all countries sold. LifeVac is CE-marked and also receives regulatory body inspections. Being a regulated medical device, the LifeVac® is monitored for any harm or failures. LifeVac is the only non-invasive regulated airway clearance device/anti choking medical device.

You should never trust something that “looks like” a LifeVac® medical device in a choking emergency when seconds count, especially from sites such as Amazon, Ebay, Aliexpress, Fruugo, Ozerty or other “standalone” websites and social media posts, as these platforms do not check any local or global legal/regulatory requirements for medical devices.

These devices that claim to be “choking rescue devices”, “anti choking devices”, “choking suction devices” or “medical devices”, and they have tried very hard to “look like” a genuine LifeVac®. In some listings, the sellers even use our trademarked name LifeVac®, our logos, images, and lives saved videos. But to put it simply, they are NOT LifeVac® and the device they are selling is NOT a regulated LifeVac® device nor even a functional medical device - it is simply a poor, cheaply made knock-off.

What do these counterfeit devices look like?

See some of the product images below.

Why Are These Counterfeit Devices Dangerous & How Are They Sold So Cheaply?

Well there are MANY reasons as to why these counterfeit devices are dangerous, cheap and also illegal, here are just a few:

  • These counterfeit devices are not registered/regulated medical devices, they are not CE marked. They are not regulated by any countries regulatory body. This means they do not meet any safety requirements and are illegally being sold via online platforms and drop shipping websites to the general public.
  • None of these counterfeit devices has any quality checks carried out on them, there is no proof or accountability of what suction (if any) is generated when applied.
  • Many of these counterfeit devices are simply glued together, so are not durable or strong.
  • They are made of different and cheaper materials than a regulated LifeVac® medical device. This means there is no evidence they will perform in hot or cold environments. For example, if you leave one in your car in hot weather, it may melt. If you leave one in a cold car, the bellows may be too stiff to depress.
  • These devices are being assembled in factories using cheap parts and cheap labour, with no quality or safety standards.
  • All of the counterfeit devices that LifeVac® has tested have broken during our quality testing, or do not generate enough suction to relieve an obstruction in the airway. Some do not even have a one-way safety valve, this means they push air into the person when applied, which is fatal.
  • When these counterfeit devices are used and fail to remove an airway obstruction, due to not creating enough suction, or breaking or pushing the obstruction further down, there is no way the regulators can identify and prosecute the manufacturer or seller. Many of these counterfeits are now using photocopies of LifeVac USA instruction sheets, which means there is no traceability. Genuine LifeVac® devices are regulated and have traceability.
  • These illegal counterfeit devices have not saved any lives and do not have ANY testing or peer reviewed medical publications to prove how safe or effective they are.

Even regulators (like the TGA) are being fooled by these counterfeits and misidentifying counterfeits as “genuine” purely based on “a similar visual appearance”. This lack of investigative rigor has placed thousands of lives at risk and is the subject of a significant compensation claim due to defective administration leading to endangering lives.

We are now starting to see “standalone websites” and affiliate websites in Australia, drop-shipping these illegal devices to innocent people in Australia. Every site and company has or will be reported to the TGA regulatory bodies for swift legal action. Buying a counterfeit and cheap knock-off LifeVac is not a bargain if it results in the death or serious injury to a loved-one.

How do I Know if I Have an Actual LifeVac® Device?

There are several key features of a genuine LifeVac® that can identify its authenticity. Firstly, the bottom of the device is stamped “Made in the USA”, however, some of the latest fakes even copy this, in an attempt to fool the public and regulators. Every LifeVac® device sold in Australia and New Zealand has literature which has LifeVac Australia contact details and regulatory details printed inside, including an ARTG number and batch details. All LifeVac® devices come with a QR code that links to our TGA registration. Of course, all genuine LifeVac® are fitted with our patented one-way valve assembly. There are many more ways that we can tell if you have a genuine LifeVac® medical device. We cannot share this information publicly, otherwise counterfeiters will also try to copy these details.

We can help you identify a counterfeit by contacting us on 1300 890 345 or emailing via sales@lifevac.net.au

What Are LifeVac Doing to Stop This?

As you can imagine, setting the bar also comes with responsibility. LifeVac are doing many things to address this, including: taking legal action for patent infringement, intellectual property and design right infringement, constantly reporting breaches and illegal activity to the regulator, and warning the selling platforms. So far, despite the clear risk to public safety, the Australian regulator has not taken any effective action to stop this or warn the public. (MHRA, the equivalent regulatory body in the UK, has taken action by means of an urgent recall).

What Can I Do To Help?

If you see a seller within your country illegally selling these dangerous counterfeit devices, you can also report them to your country's regulatory body (TGA in Australia) and the platform you saw them listed on. Under the Therapeutic Goods Act, it is illegal to advertise, or cause to be advertised (by any means) counterfeit therapeutic goods (including medical devices). It is also illegal to sell medical devices in Australia without an ARTG number.

 

 

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