FAQ – Frequently Asked Questions

What is the AVACEN 100 and Single Point Treatment?

The AVACEN 100 is a patented and FDA-Cleared Class II medical device that uses cutting edge technology developed by AVACEN Medical. It incorporates heat therapy and negative pressure to increase local circulation and infuse heat into a unique vascular network, located in the palm of the hand. Raising the blood temperature at this “single point treatment” (the palm) increases blood temperature throughout the body naturally via the circulatory system. This can benefit the entire body.

 

How do I use the AVACEN 100?

Simply place your hand into the AVACEN 100 for a comfortable treatment session. Session duration can range from ten to thirty minutes depending on your needs. Easy to understand instructions are presented on the device Display Screen. If you use the preset AVACEN 100 defaults, only a single button press is required! The AVACEN 100 works with the body’s natural adaptations. It’s easy to use and noninvasive.

 

What is The AVACEN Treatment Method?

The AVACEN 100 uses the AVACEN Treatment Method (ATM) – a noninvasive pain management technology platform for people at normal body temperature. This technology platform uses a microprocessor controlled chamber to surround the hand with a slight negative pressure, while adding heat to the palm. This negative pressure expands the volume of blood in the palm’s unique vascular networks while heat is simultaneously transferred from the computer managed palm pad into these expanded vascular networks.

 

Can’t I just put my hand into some very warm water?

No. The body has a thermoregulation system that protects it from too much external heat or cold. The key to this regulation process is the body’s ability to vasoconstrict (close) the heat exchange vascular networks; this happens when the hand is placed in very warm water. The AVACEN 100 methodology uses negative pressure to dilate (open) these networks in the palm so it can continue to infuse heat at a safely managed level.

 

Is the AVACEN 100 for me?

Are you dissatisfied with your current pain treatment regimen? Are you looking for a drug-free alternative with no side effects? If yes, then the AVACEN could be exactly what you’re looking for. The AVACEN 100 is the answer for many people who need or prefer an easy to use, drug-free alternative for temporary relief of pain, which might be associated with a variety of chronic and acute medical conditions.

Besides avoiding the detrimental effect of possible damage to the heart or liver by some pain medications you may want to try the AVACEN because of an insufficient response to pain medications, as a drug-free alternative if you are pregnant, nursing, or pre-pregnancy, or if you simply are looking for a healthy and homeopathic solution. You still need to consult with a Doctor before using the AVACEN 100 if you are under 18 years of age, are pregnant, have a history of heart disease, blood circulation problems, have a temperature higher than 99.5ºF or any other medical concerns.

 

Will the AVACEN 100 work for me?

Chances are yes, but we honestly cannot know for sure until you try it out. About 1 out of 10 users report low or no pain relief, which is why we created our Money-Back Guarantee. We believe in the pain relief properties of the AVACEN 100, and want to ensure you face as little risk as possible when testing out this new treatment method. Will you be in the 90% of users that feel better when using the AVACEN? Will you be in the 70% of AVACEN users that no longer need their prescription drugs? There is only one way to find out.

 

Can it really be that simple?

Increasing your body’s blood temperature from within your vascular network, rather than from outside with the use of a spa, sauna, or heating pad is the key to the entire process. The palm of the hand is one of the best places for applied heat therapy because of the unique network of blood vessels that exists very close to the skin.

When your body naturally heats up, it pumps more blood to your hands and feet to dissipate the excess heat. That’s why you can stick your foot out of the covers at night and cool off so easily. The AVACEN has reversed that process to help you improve your body’s microcirculation.

While this method seems simple, it was actually overlooked as a treatment solution because, except for the intentional creation of hyperthermia to treat cancer, the primary purpose for infusing heat into the circulatory system was to move people suffering from extreme cold and shock to normal body temperature as safely as possible. And when the body recovered, the job was done and there was no need for further warming or testing.

Our patented AVACEN Treatment Method (ATM) continues infusing heat into the circulatory system for people with a normal body temperature. The result is: the body works to dissipate this unwanted infusion of heat by pumping warmed blood through deep tissue, causing blood vessels and capillaries throughout the body to expand in order to dissipate this excess heat. This normal thermal-exchange process is called radiation. This results in significant benefits for arthritis and muscular relaxation.

 

What is the cost?

$2995

The unit retails for $2995 and has an operating lifetime of 5-10 years which works out to just over $25-$50 per month or $.83 to $1.66 per day. When compared with the cost of current drug alternatives, the AVACEN 100 may likely save you money long-term, if you use it instead of your drug regimen.

Humira (without insurance) – $873 per pen, requires 2 per month = $1746 / month
Enbrel (without insurance) – $1,500 per month
Remicade costs – $1,300 per month
AVACEN 100 – ~$50 per month

We know $2995 may feel like a lot to invest up front, but between the feeling of pain relief, the Money-Back Pain-Free Guarantee, and the savings you can have from your drug regimen the AVACEN 100 may save you up to $1696 per month!

 

What is the warranty?

The AVACEN 100 comes with a standard 3-Year Warranty. Please see the consumer and commercial warranty for details.

 

Do you have a trial period?

Yes. There is a 60-day Money Back Guarantee. For details on our 100% Money Back Guarantee, please CLICK HERE.

 

What if I want to return the device?

If you need to return (including warranty claims), you MUST have a Return Merchandise Authorization (RMA) Number and you must write the RMA on the outside of the return box. To get your RMA: email your request to RMA@avacen.com with the serial number of your product (found on the bottom of the AVACEN 100). Your Return Merchandise Authorization (RMA) Number can only be issued by AVACEN Medical Customer Service. Returns WILL NOT be accepted without a valid RMA.

REFUND DETAILS:

Only one device per original purchaser can qualify for the payment reimbursement. Discounted devices do not qualify for money-back returns. When two devices are purchased and one is being returned, the refund amount is based on the lower-priced device.

To qualify for 90% payment reimbursement you will need to: (1) be an original purchaser and follow our clinically proven use protocol of 15 minutes twice daily (early morning and before bed) for at least 50 of the 60 days; (2) request a Return Merchandise Authorization (RMA) from customer service (RMA@AVACEN.com) within 70 days of AVACEN 100 delivery to you and ship the AVACEN 100 back within 5 days receiving your RMA and; (3) return the AVACEN 100 in a ‘like new’ condition, including manuals and re- packed in the original shipping container. An accepted Equipment Purchase Agreement (either online or written) is required prior to shipping to qualify for any refund. Only original non-expedited shipping is reimbursed.

OTHER REFUNDS:

Should you NOT comply with (1) above but meet the terms of (2) and (3), you can still return your purchase and will be refunded as follows: (i) Upon returning your AVACEN 100, if received in a ‘like new’ condition, you will be refunded eighty percent (80%) of your original product purchase price to offset costs such as depreciation, refurbishing, re-packaging and re-certification. To allow proper inspection of returned products, refunds will be processed within 15 days after return is received.

The above refunds require the RMA request from customer service (RMA@avacen.com) is made within 70 days of the AVACEN 100 delivery to you and you must ship the AVACEN 100 back within 5 days of receiving your RMA. No refunds will be issued OR RETURNS ACCEPTED if these policies or timelines are violated in any way.

 

Please visit https://AVACEN.com/RMA for complete Return Merchandise Authorization (RMA) Process Details

 

Are there any payment plans?

Yes. PayPal Credit offers an option of No Payments + No Interest if paid in full in 6 months or monthly payments of 3% of the outstanding balance. For credit eligibility and payment details, please click on this PayPal Credit FAQ Link.

 

Will my insurance or Medicare pay for the AVACEN 100?

Unfortunately at this time, insurance or Medicare does not cover this medical device. Even though the AVACEN 100 brings relief to the suffering of patients that have found no other remedy for their pain; in the eyes of the insurance companies, the AVACEN 100 is currently considered experimental technology.

The necessary studies to qualify the AVACEN 100 to be covered by insurance will cost millions of dollars and could take many years. Therefore, we have decided not to take the reimbursement path for the time being in order to make the AVACEN 100 available today at a reduced cost (such studies could add 75% to the eventual device cost).

If you have a Healthcare Flexible Spending Account (FSA) or Health Savings Account (HSA), you may be able to purchase the AVACEN 100 using that option.

 

Do I need a prescription?

No. The AVACEN 100 is an over-the-counter (OTC) class II medical device cleared by the FDA. A prescription is not needed but before purchasing, please read the User Guide which contains information on Intended Use, Instructions, Contraindications, Warnings and Precautions.

 

Can the AVACEN 100 be shared?

Yes. The AVACEN 100 includes numerous ease of use and safety innovations. One of these is the custom mitt which allows multiple users to experience AVACEN 100 benefits when sharing a single machine.

 

How long should one mitt last under normal use?

One mitt should last a single user 2-3 months under normal twice daily use. The package of 25 mitts that arrives with the AVACEN 100 should last one user at least 4 years or 2 years for two users. Mitts should only be reused by the same person

 

Are there any negative side effects to using the AVACEN 100?

The AVACEN 100 noninvasive treatment method, mitt and the relatively low heat transfer temperature minimizes potential safety problems. No serious negative side effects have been observed using the AVACEN Treatment Method in over 2 Million treatments.

 

What else should I know about the AVACEN 100?

For more details on Contraindications, Warnings and Precautions view the AVACEN 100 User Guide.

 

Is the AVACEN 100 FDA 510(k) Cleared?

Yes. The AVACEN 100, a Class II Medical Device, is cleared as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and minor sprains; muscular relaxation; and the temporary increase in local circulation where applied.

 

Is the AVACEN 100 CE Marked?

Yes. The AVACEN 100, a Class IIa Medical Device, is cleared as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and minor sprains; muscular relaxation; for the temporary relief of widespread pain associated with fibromyalgia and; the increase of microcirculation.

 

Is the AVACEN 100 Health Canada Approved?

Yes. The AVACEN 100, a Class IIa Medical Device, is cleared as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and minor sprains; muscular relaxation; for the temporary relief of widespread pain associated with fibromyalgia and; the increase of microcirculation.

 

Who developed the AVACEN 100 and The AVACEN Treatment Method?

The AVACEN 100 and The AVACEN Treatment Method (ATM) were invented and developed by AVACEN Medical of San Diego, California. Both the AVACEN 100 and AVACEN Treatment Method are protected by one or more of the following U.S. patents: 8,679,170; 9,066,781, 9,192,509,  9,687,385 and multiple international equivalents.

 

Who Manufactures the AVACEN 100?

AVACEN Medical is the FDA registered manufacturer of the AVACEN 100 which carries the coveted “Made in the U.S.A.” distinction. AVACEN Medical was founded in 2009 and is headquartered at 9835 Carroll Centre Rd #104, San Diego, CA 92126. AVACEN can be contacted at (888) 4-AVACEN or info@AVACEN.com.

 

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