NEW FROM FDA!
General Wellness: Policy for Low Risk Devices Guidance for Industry
and Food and Drug Administration Staff Contains Nonbinding
Recommendations Table of Contents
I. Introduction 1
II. Policy on Low Risk General Wellness
III. General Wellness Products
IV. Determining Risk for General Wellness Products
V. Examples of General Wellness Products that Are Not Medical
Devices and Examples of General Wellness Products that Are Medical
Devices for which FDA Does Not Intend to Enforce Requirements
VI. Determining whether General Wellness Products are within
Scope of the Guidance
The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1 This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2
Rhythmic control of ‘brain waves’ can boost memory
Brain waves can be controlled in a number of ways. They can be modulated using sounds and images, as well as non-invasive electrical and electromagnetic oscillations.
Dr Simon Hanslmayr, from the University of Birmingham’s Centre for Human Brain Health, commented: “We can modulate memory performance via rhythmic neural stimulation, which can be as simple as flickering light at a particular rhythm which then is followed by neurons in the brain.
Neuroscientists discover neuron type that acts as brain's metronome
By measuring the fast electrical spikes of individual neurons in the touch region of the brain, Brown University neuroscientists have discovered a new type of cell that keeps time so regularly that it may serve as the brain's long-hypothesized clock or metronome.
Nerve stimulation and repetitive sounds help improve hearing
Combining seizure-preventing electrical stimulation with repetitive musical tones improves processing of sounds in the brain, according to new research. The discovery may provide relief for chronic ringing in the ears (tinnitus) and aid communication skills in people with autism. The first-of-its-kind study, published ahead of print in the Journal of Neurophysiology (JNP), was chosen as an APS select article for August.
The brain is a muscle and if you continuously keep giving it a better way to function, neuroplasticity kicks in, what that means is the brain can be trained to be re-wired. It can also be trained to create new wires so messages can travel better and faster. Bellabee helps this process, because it trains the brain to resonate at better levels.
BELLABEE wearable, your personal performance booster. Using MEDICAL KNOWLEDGE Bellabee can calm you down, reduce tension and prepare you to fall asleep easily. SIMPLY BY SUGGESTING YOUR MIND AND HEART A SPEED THEY SHOULD PERFORM IN.