The Palm Pistol Has Been Creating Quite A Stir In The News Media.
This has been overwhelming and very unexpected.
Constitution Arms Palm Pistol – -(AmmoLand.com)-You may have been following our interactions with the FDA. On December 2, 2008, we were directed by the agency to register our company as a “medical device establishment” and list the Palm Pistol as a “device.” They told us the Palm Pistol would be a Class I Exempt medical device in accordance with 21 CFR 890.5050 Daily Activity Assist Device and would have a product Code ILT. We followed their instructions and completed our registration and listing using their online FURLS system. Once complete, we were informed we were permitted to engage in commercial activities. On December 8, 2008, following wide domestic and international news media coverage of our product, and we can only assume in response to certain political pressures, the FDA cancelled our previously issued establishment registration and device listing, claiming the original action was done in “error.”
This turn of events will have no impact on our plans. Unfortunately the only effect will be upon seniors and disabled. They suffer a disproportionate share of becoming victims of a crime, precisely because they are one of the most weak and vulnerable segments of society. These same people are often at an economic disadvantage and cannot afford to purchase firearms for lawful self-defense. If the FDA had stood by its initial assessment to classified the Palm Pistol as a medical device, at the very least, it may have been possible for seniors and disabled to request partial reimbursement from private health insurance companies. We also would have argued that the cost of this adaptive aid should be covered by Medicare. It is quite ironic that certain elements of the political spectrum demand more protection for the weak, yet when someone steps up to the plate to provide that protection, to empower the weak from predators, they somehow cast a blind eye to their needs.
The good news is, with all this unplanned publicity, we are well on our way towards reaching our goal of 200 pre-production reservations. Those of you have so far reserved a Palm Pistol, we owe a debt of gratitude. For those who have not yet taken action, we urge you to do so. While commercial success is certainly an important consideration, we are firm believers in the Second Amendment and the right to self-defense. The Palm Pistol is one small means to make an immediate difference. He who can only do little, is not excused from doing nothing.
Matt Carmel, President
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