Dechoker Receives FDA Class II Medical Device Registration for Choking First Aid Product March 28, 2016 12:07
Dechoker LLC, a Salisbury, North Carolina-based company announced that on March 1, 2016, it received the FDA Class II Medical Device Registration for its Dechoker Anti-Choking Device products. These devices are used to quickly and effectively remove materials, debris, fluid, etc. from a choking victim's airway, and have a Quality Management System (QMS) that comply with FDA 21 CFR Part 820 and ISO 13485:2003
The Dechoker is a revolutionary life-saving device that is changing the way people respond in a choking emergency. This first aid for choking device can be used to save lives in community gathering places such as homes, restaurants, schools, office buildings, sports venues, etc. in addition to providing another option of therapy for ambulances and health care facilities.
“Obtaining our Class II Registration, in conjunction with our QMS, ensures the highest quality manufacturing standards and processes are being followed and allows us to qualify for the Reimbursement Programs for those who are eligible”, says Alan Carver, the Inventor and CEO of Dechoker.
“Having a disabled grandson with daily choking possibilities, I see firsthand the emotional burden placed on parents and family members, not to mention the financial hardship. The Dechoker is an easy-to-use product that everyone should have in case of emergency. Being a part of the Reimbursement Program gives those with choking illnesses access to this product that they would not otherwise have. We built this company with the goal of eradicating choking deaths; all individuals need access to this life-saving product for that to happen.”
The Dechoker device helps augment or replace abdominal thrusts for choking victims, especially when the maneuver has been done incorrectly or ineffectively. The thrusts have limitations, especially for those who are pregnant, elderly, or obese. There are over 60 million individuals with medical conditions that increase their risk of choking, including dysphagia, Down syndrome, cerebral palsy, multiple sclerosis, Alzheimer’s disease, etc.
Interest in the device has come from a variety of industries all across the world including, personal home use, assisted living facilities, nursing homes, EMS services, police departments, restaurants, casinos, hotels, cruise ships, daycares, educational institutions, airlines, military bases, corporate break rooms, and others.
The Dechoker device was also designed with the vast oceans, rural areas, and wilderness in mind. In the amount of time it takes for emergency personnel to reach remote areas, it may be too late to help a choking victim. The Dechoker is easy enough for anyone to use, and can even be self-administered. It is available in an adult size (12 and up) as well as child (3 to 12 years) and toddler sizes (12 months to 5 years).
About Dechoker LLC:
Founded in 2011 and created with the intent of eradicating choking deaths, we are striving to bring choking awareness and end accidental choking deaths globally. Breathing is Mandatory™ is not just our motto, it is our vision.
For more information about the Dechoker or to schedule an interview, please contact:
Director of Strategic Development