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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
BrainPort is a technology whereby sensory information can be sent to one's brain through an electrode array which sits atop the tongue. [1] It was initially developed by Paul Bach-y-Rita as an aid to people's sense of balance, particularly of stroke victims. Bach-y-Rita founded Wicab in 1998. [2] [3] [4]
The original PEMF devices consisted of a Helmholtz coil which generated a magnetic field. The patient's body was placed inside the magnetic field to deliver treatment. Today, the majority of PEMF wellness devices resemble a typical yoga mat in dimensions but are slightly thicker to house several flat spiral coils to produce an even electromagnetic
A tongue depressor or spatula is a tool used in medical practice to depress the tongue to allow for examination of the mouth and throat. Hobbyists , artists, teachers and confectionery makers use tongue depressors, which may also be referred to as craft sticks or popsicle sticks .
TENS unit is a medical device for pain relief. The desired outcome is to reduce pain by stimulating different nerve signals. EMS fitness is also an FDA-cleared medical device but meant for muscle development. EMS fitness is designed to stimulate all the major muscle groups to elicit strength and endurance adaptations."
The most common use of SCS is failed back surgery syndrome (FBSS) in the United States and peripheral ischemic pain in Europe. [4] [5]As of 2014 the FDA had approved SCS as a treatment for FBSS, chronic pain, complex regional pain syndrome, intractable angina, as well as visceral abdominal and perineal pain [1] and pain in the extremities from nerve damage.
Extracorporeal shockwave therapy is used as a second line measure to treat tennis elbow [9], [10] [11] shoulder rotator cuff pain, [12] [13] Achilles tendinitis, [14] [15] plantar fasciitis, [16] [17] and greater trochanteric pain syndrome. [18] ESWT is also used to promote bone healing and treat bone necrosis. [19]