February 15, 2007
PowerLung products listed as medical devices.
PowerLung, Inc. has completed the documentation necessary to have all seven (7) of its models in both the Active Series and the Performer Series registered with the US Food and Drug Administration (FDA) as Class I Medical Devices - Exercise Equipment. Companies listing with the US Food and Drug Administration (FDA) as medical devices are required to adhere to good manufacturing practices in order to assure the products they manufacture or distribute meet quality standards. According to Carolyn Morse, President of PowerLung, Inc., "the company took this step to demonstrate to its customers we are making the extra effort required to comply with the FDA and we take quality products very seriously." "PowerLung has always labeled its products according to FDA guidelines," said Morse, "we wanted to be sure our customers were sure we were adhering to all the regulations for labeling and advertising our products and not making false claims or statements like so many of the less expensive gimmicky products do. There is an extra cost associated with taking this step and our customers are don't mind because they know PowerLung is not a gimmick or gadget but can really do what it claims." PowerLung products are listed as exercise equipment because the products use the proven methods of progressive threshold resistance to offer their training for inhale and exhale. No other company has a product that can offer this comprehensive training and flexibility. Morse explained how PowerLung is classed with the FDA as exercise equipment. "When you go to the gym to exercise you use a specialized machine with progressive threshold training to exercise specific muscle groups. When you use a Bowflex®, or a Total Gym® or free weight exercises you are also using progressive threshold training. Those machines and products often cost thousands of dollars and PowerLung for about $100 gives this same proven training for the muscles you use to breathe. No other exercise or training product can offer this specialized training. AND, it is hand held, drug free and takes only a few minutes a day. You can even use it sitting down. It's easy to see why it has become so popular for so many different types of users." PowerLung, Inc. has been marketing products for breathing training and respiratory muscle training since 1999. Independent, third party studies on the product have documented and substantiated PowerLung products capabilities and claims. This research has also aided in the development of new products. PowerLung is the only company with products tailored to meet the needs of a variety of users from athletes to musicians and vocalists. Active Series products focus on all levels of individuals who desire and active or competitive lifestyle while Performer Series products focus on all levels of individuals in the performing arts or public speaking. "We have always developed our products based on research and what our customers have told us would work for them," said Morse. You can find more information on PowerLung products at www.powerlung.com. |