Forum

Notifications
Clear all

General Wellness Product

33 Posts
30 Users
0 Reactions
4,007 Views
(@djr32)
Posts: 39
Eminent Member
Topic starter
 

According to the FDA, general wellness products are “(1) intended for maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that related the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions.” The Center of Device and Radiology Health defines these products have two factors: (1) intended for ONLY general wellness use and (2) present a low risk to the safety of users and other people. (Look at the reference if further information is needed for general wellness products)
The FDA categorizes general wellness products into 2 categories:

(1) In the first category, the products intend to offer a general improvement to functions associated with general health that does not make any reference to diseases or conditions.

(2) In the second category, the product intended uses relate to sustaining or offering a general improvement to function while making reference to diseases or conditions.

Provide an example of a general wellness product, such as a Fitbit in the previous question I posted. What category does this general wellness product fall under? Why?

Reference:
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf

 
Posted : 06/02/2017 12:32 pm
(@bb254)
Posts: 113
Estimable Member
 

A lot of college students undergo a large amount of stress and are always trying to find ways to get more sleep. The sound + sleep product promotes “relaxation, renewal and deeper sleep.” It is a general wellness product because it has very low risk. It plays natural music which calms individuals down and allows for people to enter a more relaxed mental state. This product allows the user to enter a deeper sleep cycle even though you might not sleep for more than 5 hours. This product would be great for college students such as myself. This product claims to relax individuals but is not FDA regulated to make sure that it improves the consumers sleep cycle. It is not claiming to improve the health of people with sleep management or anxiety issues. This products claims are for the general health and are not pertaining to a specific illness therefore it is considered to be a category 1 general wellness product.

Reference:
https://www.soundofsleep.com/soundsleep/

 
Posted : 06/02/2017 12:39 pm
(@talha-chaudhry)
Posts: 39
Eminent Member
 

I'm actually using this biomedical device for my capstone project. It's called the comfortprene wrist and thumb-wrap. It's a general wellness product that would fall into the second category of the FDA's definition of said general wellness products. The reason being is that this brace is ideal for dealing and aiding ailments such as wrist arthritis, sprains, tendinitis and carpal tunnel syndrome. It falls under the second category because it is attempting to treat certain conditions while making direct reference to known diseases/ailments. The brace is providing a general improvement to function.

Source: https://www.ncmedical.com/item_1213.html

 
Posted : 06/02/2017 5:44 pm
(@jp582)
Posts: 51
Trusted Member
 

Many people want to change their unhealthy lifestyle, especially college students who do not have time for exercise and eat without counting calories. There is general wellness device called Withings pulse Ox can help someone be more active and improve health by tracking daily activities. During the day it captures steps, distance walked, elevation climbed and calories burned. At night, it monitors your sleep cycles. And when asked, it measures your heart rate and blood oxygen level. With this data at hand, Pulse Ox reinforces your motivation, instantly know how many calories you burned on daily basis. I would say this Pulse Ox device is in the first categories because product monitors a general wellness activities that does not diagnose or treat disease.
http://www.withings.com/us/en/products/pulse

 
Posted : 07/02/2017 6:57 pm
 jvv6
(@jvv6)
Posts: 31
Eminent Member
 

In the summer, whenever it was one of those hot summer days sometimes a dehumidifier is used to reduce the humidity levels of your household. Dehumidifiers are basic household appliance that I believe can be classified as a general wellness product because of its uses. Since they reduce household humidity levels, this reduces the likelihood of allergens such as mold, mildew, and dust mites in the air. A lot of these allergies trigger symptoms such as itchy/watery eyes, a stuffy nose, sneezing, difficulty breathing, wheezing, and skin rashes. Since it offers general improvements to functions associated with general health, they would most likely be classified as a Type 1 general wellness product.

 
Posted : 08/02/2017 12:23 pm
 jvv6
(@jvv6)
Posts: 31
Eminent Member
 

Another product that I believe could be classified a general wellness product would be the opposite of dehumidifiers, humidifiers. Unlike their counterpart they're mostly used in the winter time. I remember during undergrad I would have those weird roommates who'd keep the window slightly open and it actually made sleeping really uncomfortable throughout the night, because I'd end up with a sore throat and cough all night. So during these winter months I used a humidifier which relieved me of these symptoms. Not only do humidifiers claim to reduce the likelihood of sore throats and coughing, but it also prevents dry skin/chapped lips, and possibly bloodshot eyes. This is all because dry air conditions may pull moisture out of your body since the body is composed of large amounts of water. Like dehumidifiers, these would be Type 1 general wellness products because of their claims to general health conditions and not specifically making claims to diagnosing or treating a disease.

 
Posted : 08/02/2017 12:37 pm
(@gingeranderson)
Posts: 78
Trusted Member
 

For me personally, I think of a yoga mat. It is intended "for maintaining or encouraging a general state of health or a healthy activity". It is intended for only general wellness and is low risk. A yoga matt would fall into category (1). It is not intended for a specific disease but can be used for lower back pain, mental therapy through meditation, or many other conditions. I personally have used it for lower back pain and can say that it works much better than a chiropractor. It also provides a place to relax after a long day, relieving stress that is associated with a number of chronic conditions and diseases.

 
Posted : 09/02/2017 8:10 am
(@akshay-sakariya)
Posts: 41
Eminent Member
 

In the late spring, at whatever point it was one of those hot summer days some of the time a dehumidifier is utilized to diminish the dampness levels of your family. Dehumidifiers are essential family unit apparatus that I accept can be named a general wellbeing item in view of its employments. Since they diminish family unit mugginess levels, this lessens the probability of allergens, for example, shape, buildup, and tidy bugs noticeable all around. A great deal of these hypersensitivities trigger manifestations, for example, bothersome/watery eyes, a stuffy nose, sniffling, trouble breathing, wheezing, and skin rashes. Since it offers general enhancements to capacities related with general wellbeing, they would in all probability be delegated a Type 1 general health item.

 
Posted : 09/02/2017 3:03 pm
(@bv87)
Posts: 29
Eminent Member
 

Health apps could be considered a general wellness product. These apps allow users to count their daily calories and facilitate their exercise routines. Therefore these apps help to maintain healthy lifestyle and prevent the chronic diseases. I consider this product as a second category since it makes a direct reference to the diseases such as diabetes and cholesterol.

 
Posted : 09/02/2017 6:00 pm
(@krp76)
Posts: 76
Trusted Member
 

One basic example of a general wellness product would be the recently released amazon echo dot. The echo dot has many functionalities and can be considered a low risk general wellness product because it provides ambient sounds such as white noise and other relaxing sounds for promoting sleep and relaxation. Moreover it has features called "skills" such as mindfulness which is a form of meditation that addresses stress-relief and relaxation. Therefore, this device would fall under the first category of general wellness, according to the FDA guidance.

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf

 
Posted : 10/02/2017 6:01 am
(@akshayakirithy)
Posts: 65
Trusted Member
 

We can simply take gym equipment as a example for general wellness device. Let's take a treadmill. Treadmills offer a versatile way to exercise regardless of whether or not the weather chooses to cooperate with your fitness plans. Walking on a treadmill works the same muscles that walking on a track or outdoors does. Walking on a treadmill can improve cardiovascular health and burn calories leading to weight loss. Even it improves the psychological strength of being positive towards the health issues. As we already know exercise is essential for everyone's life. Even this one sometimes used to improve the heart rate and helps in rehabilitation following a stroke.

 
Posted : 10/02/2017 6:57 am
(@hiren-rana)
Posts: 36
Eminent Member
 

I think helmets could be considered a general wellness device. Helmets are used to provide support to your head and lower the risk of injury. It provides the basic necessities to reduce the risk of traumatic brain injuries to a wide array of occasions. My Capstone project is studying the effects of TBI's by measuring brain deformation caused by force impact on the skull. When doing our market research, we looked at a variety of helmets used by the military and looked into how they lowered impacts to the head from shrapnel and explosions.

 
Posted : 11/02/2017 11:22 am
 tn58
(@tn58)
Posts: 72
Trusted Member
 

I personally take women's one day multivitamin as recommended by my doctor. During undergraduate years, I was going through extreme stress and anxiety with college courses as well as work life. This resulted in loss of appetite and dehydration and lack of certain vitamins in my body. This one pill actually helped me get back on track and regain my appetite and make sure my body was getting the essential vitamins and minerals. So I would categorize this a category I general wellness product. As vitamins are used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health.

 
Posted : 11/02/2017 6:26 pm
(@myton)
Posts: 77
Trusted Member
 

What about sports shoes? For running shoes, its intended use is for strenuous physical activities such as running. There are also basketball shoes which are intended for people who play basketball in order to promote better performance but also for ankle protection during playing. Since these physical activities are considered as exercise. Cardiovascular exercises are important because of their many benefits and these shoes are accessories that help in performing them. In my opinion, they would count as the first category because it’s meant for overall general wellness.

 
Posted : 12/02/2017 1:31 pm
(@eac25)
Posts: 32
Eminent Member
 

This may be a strange angle to take, but I think those "energy wristbands" that were a mild craze a while ago can be considered a general wellness product. These were ordinary bracelets that were advertised to give you more energy throughout the day. They've obviously been debunked in their efficacy, but for the many people that bought into it, it arguably gave them a strong placebo effect. This itself can be a huge boon, even it's not the effect it was advertised to give.

 
Posted : 12/02/2017 2:38 pm
Page 1 / 3
Share: