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Benefit from D’OXYVA’s IDE status

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

By virtue of the fact that Institutional Review Boards (IRBs) approved human clinical studies with D’OXYVA®  and concluded that it was a Non-Significant Risk (NSR) device, D’OXYVA®  has an approved Investigational Device Exemption (IDE). See 21 CFR 812 reference below in section (b) and (1) highlighted in CAPITAL LETTERS.

This means D’OXYVA can be used for any medical purposes under testing (investigations). Doctors can ask their patients if they would like to try and test D’OXYVA®  for a certain period of time to see if it helps their condition. First, D’OXYVA should be used as an adjunct application combined with other therapies (no negative interference with other modalities has been reported to date). Typically, patients should test D’OXYVA®  for the first time for 6-8 weeks twice a day for the first two weeks and then once a day to achieve best results according to various clinical trial results and user feedback with D’OXYVA® . Severe cases should continue using it twice a day for 4 weeks and then based on progress lower dosing to once a day.

(b) Abbreviated requirements. THE FOLLOWING CATEGORIES OF INVESTIGATIONS ARE CONSIDERED TO HAVE APPROVED APPLICATIONS FOR IDE’S, unless FDA has notified a sponsor under 812.20(a) that approval of an application is required:

(1) AN INVESTIGATION OF A DEVICE OTHER THAN A SIGNIFICANT RISK DEVICE, if the device is not a banned device and the sponsor:

(i) Labels the device in accordance with 812.5;

(ii) OBTAINS IRB APPROVAL OF THE INVESTIGATION AFTER PRESENTING THE REVIEWING IRB WITH A BRIEF EXPLANATION OF WHY THE DEVICE IS NOT A SIGNIFICANT RISK DEVICE, AND MAINTAINS SUCH APPROVAL;

(iii) Ensures that each investigator participating in an investigation of the device obtains from each subject under the investigator’s care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 56.109(c).

(iv) Complies with the requirements of 812.46 with respect to monitoring investigations;

(v) Maintains the records required under 812.140(b) (4) and (5) and makes the reports required under 812.150(b) (1) through (3) and (5) through (10);

(vi) Ensures that participating investigators maintain the records required by 812.140(a)(3)(i) and make the reports required under 812.150(a) (1), (2), (5), and (7); and

(vii) Complies with the prohibitions in 812.7 against promotion and other practices.

 
 
 
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How does Poor Blood Circulation Affect your Skin?

D'OXYVA | Cardiovascular, Diabetes Care, Pain Reliever in CA.

We all know how a poor blood circulation can affect our state of health but do you also know that a poor blood circulation can adversely affect our state of skin too? Well, I sort of know but I didn’t really think too much of it until I was introduced to donkey skin gelatin for beauty as I learnt from my bestie that not only did her relative’s skin tone improved after taking the herbal mixture, but her pigmentation spots actually faded because the herbal mixture promote blood circulation and increase the reproduction of cells. Now, that got me thinking that perhaps some of my skin problems might be due to a poorer blood circulation.

What skin problems can a poor blood circulation cause?
I’m not going to cite any medical studies here but if you think about it, a better blood circulation will definitely increase the reproduction of cells, and this will benefit the skin too. So while a poor skin condition could be due to many reasons, a poor blood circulation is definitely going to show up as poor skin condition. Here, I’ll cover briefly on six skin problems that can result due to poor blood circulation.

1. Unflattering skin tone

When someone is anemic and has a poor blood circulation, chances are, that person has a pallid complexion. In some cases, the skin tone is also dull and may even look ashy.

2. Skin discoloration

Poor blood circulation often results in a lack of oxygen in the blood and hence, this can also cause skin pigmentation, dark spots or blotchy complexion.

3. Acne and problematic skin

Obviously, a poor blood circulation is going to affect how some of your major organs function and over time, these organs can become stressed and are unable to eliminate toxins properly. This can put more pressure on your lymphatic system and your lymph nodes can become sluggish with toxins building up and then excreted through the skin, causing acne or other problematic conditions such as dry skin, itchy skin or even skin rashes.

4. Slower scar healing

Those with acne and have poor blood circulation may find that their acne wounds take a longer time to heal because there is less efficient transport of good nutrients into the skin cells.

5. Wrinkle formation

As mentioned, if your blood cannot circulation well, there is less efficient transport of good nutrients into the skin cells, and this can adversely affect collagen production – thereby causing wrinkle formation.

6. Dark eye circle

While not all dark eye circles are a result of poor blood circulation but because the skin in the area around our eyes is quite thin, poor circulation results in less oxygenated blood, manifesting in a bluish/purplish appearance under the eyes called dark eye circles.

How to improve your blood circulation

Actually, I noticed that my skin has improved gradually over these few months. Yes, the products I’ve used would have helped but one of the improvements I noticed was that my under eye area is no longer so dark. I don’t need to use thick concealer and can make do with normal foundation. At first, I thought the eye cream I am using has helped but I doubted because external products don’t help my under eye area very much except for reducing the fine lines. Then I remembered that I’ve been taking Fit Solution for over six months now and that health supplement has definitely been improving my blood circulation. In addition, I noticed that my acne healing is much faster these days too.

1. Diet and health supplements

A balanced diet rich in vitamin B, C, D and E will be helpful. However, if you find that you are not getting sufficient sources from your food, try taking a vitamin supplement if that is a comfortable idea to you.

2. Exercise

I don’t exercise but it is a sure way to increase blood circulation. In fact, as soon as you start exercising, you’ll notice that your complexion might start looking rosier because of the increased blood circulation that shows up on the surface.

3. Massage

Due to the physical manipulation of soft tissue and also the chemicals released in our bodies as part of the relaxation response, massage increases the circulation of blood. Such an improved circulation can enhance the delivery of oxygen and nutrients to skin cells. So both body and facial massages are good to indulge in for a better blood flow.

I think someone who is healthy is likely going to have a better blood circulation than one who is not. So if you suspect that your blood circulation is causing your skin problems, perhaps it’s time to improve your diet or take time to exercise for the blood flow to circulate better.