fda standards 2017-12-08T03:36:16+00:00

FDA Registered Carpal Tunnel Treatment – Carpal Solution

The elastic soft foam core center component has been specially engineered from a confidential combination of medical grade closed-cell polyvinyl chloride foam and polyurethane adhesive film to achieve the optimum balance of comfort, elastic tension, structural strength, ergonomics, hypoallergenicity and cost performance.The Carpal Solution has been designed for proactive discriminating healthcare consumers. It is constructed of carefully selected hypoallergenic materials and is manufactured in an FDA Drug & Device registered facility. The Carpal Solution is manufactured in compliance with FDA standards for medical device manufacturing with quality systems that are ISO9002:1994 and 13488:1996 certified. The materials of construction are as follows:

Medical grade ethylene vinyl acetate (EVA) adhesive wrist-straps and thumb strap are attached to the elastic soft foam core center through a unique process designed to achieve the appropriate strength and ergonomic comfort. The Carpal Solution employs the same adhesive used in hospitals to secure IV’s and tubing to patient’s skin before, during, and under post surgical care. It is tested to the highest standards of the US Food and Drug Administration (FDA).

The ethylene vinyl acetate straps are carefully perforated, to serve several important functions. First to allow the Carpal Solution to be easily custom fit to each user’s unique hand size and shape with minimal effort and no extra equipment. It is a key part of the easy three-step self application that makes the Carpal Solution readily usable by millions as a reliable self-treatment device to eliminate the symptoms of Carpal Tunnel Syndrome. The perforation also enhances breath-ability of the polyethylene straps for user comfort during the 6 to 8 hours of sleep. The tear-away straps also limit the amount of tension that can be applied with a built in burst-strength safety feature.

All straps are supplied with a paper liner on the underside to protect the hypoallergenic adhesive backing until it is ready to be self-applied.

The Carpal Solution packaging is done according to FDA Class 1 standards.

All material components have been tested in accordance with the ISO 10993 Part-1 “Biological Evaluation of Medical Devices”, as put forth by the FDA. All components have satisfied the standard testing requirements for devices in contact with skin for short term applications (up to 29 days). All laboratory testing was conducted in accordance with the FDA Good Laboratory Practices Regulation of 1978. All components are made from clinically documented hypoallergenic materials and are generally recognized as non-sensitizing to the general public. FDA Registration of Device Establishment No: 3,005,223,380.

It is rare for anyone to experience skin sensitivity issues when using the Carpal Solution. However, if any skin allergy develops from any cause, discontinue use and see a physician. Please read and follow the user-friendly application instructions and diagrams inside each package before use.

The Carpal Solution is not intended for use in the vicinity of open wounds, if an allergic reaction occurs, in conjunction with any skin disorder, or where bone fracture or bone deformity is present. There are many physiological conditions that can contribute to the onset of Carpal Tunnel Syndrome. While The Carpal Solution is designed to control the symptoms of Carpal Tunnel Syndrome, it is not intended to control these conditions, such as Auto Immune Disorders, Diabetes, Gout, Thyroid Conditions, etc. These conditions can contribute to CTS and you should see a doctor and follow his recommendations on how to treat these conditions specifically. For instance, conditions like a Thyroid Condition will bring back CTS more quickly if not treated separately from the treatment of CTS.

Do not use The Carpal Solution when wrist fractures, any broken bones or dislocations are present. Do not use Carpal Solution until at least three months after hand or wrist surgery. If any skin allergy develops while using the Carpal Solution discontinue use and see a physician. We do have some suggestions written by the Doctors on how to deal with mild skin sensitivity. If you experience mild skin sensitivity please call 1-800-798-5210.

Patients often show a wide variety of different symptoms when they have Carpal Tunnel Syndrome. Nerve Conditions are like that. Also, patients respond to the Carpal Solution Treatment in widely different ways.

Some patients experience relief from their worst Carpal Tunnel symptoms within the first 2 to 4 days (about 15 – 20%).

Most patients experience relief from their worst Carpal Tunnel Symptoms within 2 – 3 weeks. (about 65 – 75%)

Some patients take up to 5 weeks before they see any improvement (3-5%).

Once you start feeling better you can have confidence that you will get completely better with continued treatment and put Carpal Tunnel Syndrome in complete remission.

facebook reviews for the carpal solution

Carpal Tunnel is a cyclical condition. Once you get CTS under complete remission, it will go away for 2 – 7 years for most patients.

As you probably know, Carpal Tunnel comes back even after an invasive surgical procedure for over 90% of patients. 1st surgeries have a 50-60% success rate based on patient surveys, 2nd Surgeries have a 35 – 40% success rate and 3rd Surgeries for CTS are strongly discouraged by medical establishment. Surgery is a dark path, with lots of risks, downtime and repeated procedures.

Neurologists recommend the carpal solution

You are making an enlightened choice to employ a natural stretching treatment that is developed by Doctors, that jump starts you body’s natural healing process, has been clinically documented. You will likely get better without downtime, without risks and without complications associated with more invasive and risky procedures.

Once you are better and moving on with your life as normal, you will have the peace of mind knowing when CTS does come back, which it likely will, you already know how to put it back into remission quickly and without a hassle.

It is generally agreed amongst clinicians, health administrators, insurance providers and the US FDA, that less invasive treatments that are clinically documented, like the Carpal Solution Treatment is the best place to start treating chronic conditions like CTS. The Carpal Solution has a high success rate compared to other FDA Approved Treatments and Devices.

The Carpal Solution Treatment works for 97% of patients. It is non-invasive, clinically documented, reimbursed by health insurance and comes with a money back guarantee.

The FDA is aware that there is no cure for Carpal Tunnel Syndrome. So, it is a matter of trying to identify the best outcomes with the least risks, downtime and costs for the patient and the health care system. The Carpal Solution meets these criteria better than any other Carpal Tunnel Treatment. This is why Neurologists, the nerve experts in medicine, recommend the Carpal Solution Treatment as the best first line treatment for CTS. Natural treatments that actually work are ideal for treating chronic disease, because there are no side effects and no complications.

The Carpal Solution Stretching Protocol has been reviewed by the FDA and is continuously monitored. It jump starts your body’s natural healing process and gets you back to your active lifestyle in weeks.

a carpal tunnel cure developed by doctors

There is no reason to go on suffering and waiting for CTS to get better without help while worrying about the downtime and consequences of invasive carpal tunnel surgery. Get started today with a better way to treat Carpal Tunnel Syndrome that is FDA Registered and is safe, effective and been used by over 100,000 people to get better from the symptoms of Carpal Tunnel without resorting to a Carpal Tunnel Release Surgical Procedure. Thank you for your consideration.