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SEI was established in November 1995. We started as a small family business and have kept it that way. We spent most of our first
year in business locating resources and figuring out how to manufacture our restraints in a way that would keep the price competitive. Obtaining a patent and complying with the FDA's procedures were some obstacles that
we had to overcome. Over the course of the past three years we have been constantly improving on the quality of the product while keeping the price low. We are already on the third generation version of Stuckey Straps.
At first we went out and bought a few commercial sewing machines and began the task of figuring out how to make Stuckey Straps in a way that could be done fast and affordably. After we had sewn up about a
thousand straps we decided to seek outside assistance. We contracted with a couple of companies and even thought about taking our business to Mexico. In the end we decided that we wanted to keep things as local as
possible and settled in Austin with Bluebonnet Cut & Sew Co. Bluebonnet is able to keep
up with demand and they do an excellent job. If you're in Central Texas and need something sewn up commercially, give them a call.. |
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Obtaining the patent was the easy part. We have an excellent patent attorney who took care of this for us. For anyone
going through this process, be patient. It took us about a year and a half to get the patent finalized. |
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Our next obstacle was complying with all of the 510k requirements set forth by the FDA. By coincidence, the FDA changed their
policy on restraints in 1996. Restraints are now classified as a type 1 medical device. Before this, no 510k was required. SEI was one of the first restraint manufacturers to complete and submit a 510k before the
September `96 deadline. We had to change our labels several times before getting the nod from the FDA. |
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