wellness device

For import into USA we describe IBVA Brainmachine as a general wellness product.
The Draft General Wellness Guidance defines a general wellness product as a product that meets both of the following criteria :

It is intended only for general wellness use.
It presents a very low risk to user safety.
What is a general wellness use?

For the purposes of the first criterion, a general wellness use is an intended use that either relates to maintaining or encouraging a general state of health or a healthy activity, or associates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

A product’s intended use “relates to maintaining or encouraging a general state of health or a healthy activity” if the product’s sponsor claims the product sustains or generally improves conditions and functions associated with a general state of health, and such claims do not make any reference to diseases or conditions. This first category of general wellness intended uses relates to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function. The following are examples of this first category of general wellness claims:

To promote or maintain a healthy weight, encourage healthy eating or assist with weight loss goals
To promote relaxation or manage stress when there is no reference to anxiety disorders or other references to a disease or condition
To promote physical fitness, such as by helping log, track or trend exercise activity; measure aerobic fitness; improve physical fitness; develop or improve endurance, strength or coordination; or improve energy
To address a specific body structure or function, such as increasing or improving muscle size or body tone, toning or firming the body or muscle, enhancing cardiac function, or enhancing or improving sexual performance
To enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as by monitoring heart rate or monitoring frequency or impact of collisions

When does a product present more than a very low risk to user safety?

For purposes of the second criterion, the FDA cautions that the policy decision to not regulate certain general wellness products does not extend to devices that present an inherent risk to user safety. Products intended for a general wellness use that are invasive, involve an intervention or technology that may pose a risk to a user’s safety if regulatory device controls are not applied, raise novel questions or usability, and/or raise questions of biocompatibility would not meet the criteria for non-regulation under the Draft General Wellness Guidance.

Determining Risk for General Wellness Products

CDRH’s general wellness policy applies only to general wellness products that are low risk.
If the answer to any of the following questions is YES, the product is not low risk and is not covered by this guidance.

  1. 1)  Is the product invasive? NO
  2. 2)  Is the product implanted? NO
  3. 3)  Does the product involve an intervention or technology that may pose a risk to thesafety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

    The FDA guidelines list for illustration some products that are this, e.g. :
    A portable product that is intended to monitor the pulse rate of users during exercise and hiking.

    This claim relates only to exercise and hiking and does not refer to a disease or medical condition. Thus, it is a general wellness claim. In addition, the technology for monitoring pulse rate does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.

    Brain machine is a non invasive, low risk, general wellness product

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