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The device should not be used to treat skull or spinal fractures.

An evaluation of 74 non-healing (non-union) fractures submitted in a supplement for the Exogen system showed that 86% of those non-unions healed after treatment with the ultrasound signaling device. The data also supported faster fracture healing in patients treated with the ultrasound signal device compared to those who did not receive ultrasound treatment. Data from two clinical studies for that system, which produces a similar ultrasound signal to the AccelStim Bone Growth Stimulator, indicated that 108 fractures were treated without technical difficulties or any serious adverse events. The effectiveness of the AccelStim Bone Growth Stimulator is based on data from another, similar device, the Exogen Bone Healing System. Specifically, it is used to help bone fractures of the larger bone between the elbow and wrist (radius) or the larger long bone in the lower leg (tibia) heal faster. The AccelStim Bone Growth Stimulator is intended to treat bone fractures that are not healing on their own. It is used for 20 minutes once each day or as directed by the doctor. Then, the doctor prescribes the AccelStim for use at home. An agent that arouses organic activity, strengthens the action of the heart, increases vitality, and promotes a sense of well-being classified according to the parts on which they chiefly act: cardiac, respiratory, gastric, hepatic, cerebral, spinal. First, the patient receives standard treatments for their bone fracture, including a cast if needed. The ultrasound signal stimulates bone tissue for bone growth and for the bones to start reconnecting (fusion).

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The AccelStim Bone Growth Stimulator delivers an ultrasound signal through the skin to the fracture site. The AccelStim Bone Growth Stimulator device is prescribed by a doctor and used at home by the patient.

Ultrasound gel to help the ultrasound signal flow from the transducer to the fracture.

A transducer holder with an elastic strap to hold the device over the fracture.

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An external power supply/cord to power or charge the signal generator.A transducer that produces the ultrasound signal.A signal generator that controls the type of ultrasound signal needed.The portable, handheld, battery-powered device includes the following parts: Premium, FDA (k) cleared, over-the-counter Compex ® Muscle Stimulator kit featuring 10 programs that stimulate healthy muscles to help facilitate and improve muscle performance. The AccelStim Bone Growth Stimulator delivers a high frequency sound wave (ultrasound signal) to encourage bone growth and help heal broken bones (bone fractures). Product Name: AccelStim Bone Growth StimulatorĪddress: 3451 Plano Parkway, Lewisville, Texas 75056Īpproval Letter: Approval order What is it? See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. This is a brief overview of information related to FDA’s approval to market this product.