Gainswave for increasing length and/or girth?

[ItsAll4Kim]

If it matters whether its FDA-approved, let me know

It does in the US.

 

[HungCockJock]

It does in the US.

matters for what? i suggest you do your own research because i dont think the food and drug administration certifies equipment anyway. only food and drugs..

 

[ItsAll4Kim]

matters for what? i suggest you do your own research because i dont think the food and drug administration certifies equipment anyway. only food and drugs..

I didn't need to research this. The FDA regulates medical devices, the facilities that manufacture them, and the practitioners that use them.

Medical Devices

But let's not get our parties in a twist. @gsoler made one statement:

"The technology is FDA approved for use at home."

I simply asked for whatever documentation he had that stated this. It would be beyond amazing if the FDA certified such a device for home use.

 

[HungCockJock]

I didn't need to research this. The FDA regulates medical devices, the facilities that manufacture them, and the practitioners that use them.

Medical Devices

But let's not get our parties in a twist. @gsoler made one statement:

"The technology is FDA approved for use at home."

I simply asked for whatever documentation he had that stated this. It would be beyond amazing if the FDA certified such a device for home use.

Well if you want to get all technical...I did some further research for you. It does not seem this kind of device will ever undergo the steps needed for certification for the following reason

"In truth, the only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology (such as defibrillators). These are submitted to a rigorous review process called "pre-market approval" (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient"

How does the FDA 'approve' medical products?

Electroshock devices to treat ED is neither a life-threatening nor a life-sustaining device and therefore not on the FDA's priority list.
Furthermore....

"Class 2" medical devices are defined as not life-sustaining or life-threatening, though this category covers a wide spectrum of devices, from X-ray machines to some exercise equipment.

The level of scrutiny attached to Class 2 devices is much lower than Class 3. The devices do need FDA "clearance" before they can be marketed and sold, but rather than submit their products for clinical trial, the manufacturers are required instead to convince the FDA that their products are "substantially equivalent" to products that have been previously cleared by the FDA.

Substantially equivalent means that the device has the same intended use and approximate technical characteristics as an existing product.

Products that pass this clearance process may be referred to as "FDA cleared" or "FDA listed," but this is not the same as "FDA approved," which only relates to the prescription drugs and Class 3 devices that have passed PMA."

This approval method for Class 2 devices has been the subject of mounting controversy. The process is known as "510(k)" - named after its section in the law."

So it seems that class 2 devices such as those used in Gainswave treatment will never be "up for approval" but rather only need to be "cleared" to be sold in the United States. Since they are being used in medical offices I think we can assume it has been "cleared" if only for the reason that doctors would not otherwise be performing the procedures due to medical liability reasons.

 

[gsoler]

Cool. I found some statements that may be useful for us:

"The application of shock waves stimulates the soft tissues which results in significant increase of the growth factors, such as the eNOS, VEGF, PCNA and BMP expression. These processes stimulate the growth and remodeling of new arterioles."

From: Evaluation of Radial Extracorporeal Shock Wave Therapy in the Treatment of Erectile Dysfunction | Shockwave Therapy

 

[gsoler]

Then,

"In the specific case of Erectile Dysfunction, shockwave improves erections via two mechanisms:

1. Promotes angio-genesis (development of new blood vessels) in the penis which means that the blood flow to the penis increases and hence stronger erections are achieved; and
2. Rejuvenation of penis smooth muscle – the majority of patients suffering from ED do so because the smooth muscle in their penile arteries has been damaged thus inhibiting the functioning of the so-called veno-occlusive mechanism. Shockwave therapy has been shown to induce the body to repair the smooth muscle in the penis and thus improve the function of the veno-occlusive mechanism."

FRom: Shockwave Therapy for Erectile Dysfunction and Penis Rejuvenation - International Andrology London

 

[gsoler]

As it is usually the case, by itself it wont give a bigger dong, but combined with other stuff, it is of great help.

 

[ItsAll4Kim]

Well if you want to get all technical...I did some further research for you. It does not seem this kind of device will ever undergo the steps needed for certification for the following reason

"In truth, the only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology (such as defibrillators). These are submitted to a rigorous review process called "pre-market approval" (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient"

How does the FDA 'approve' medical products?

Electroshock devices to treat ED is neither a life-threatening nor a life-sustaining device and therefore not on the FDA's priority list.
Furthermore....

"Class 2" medical devices are defined as not life-sustaining or life-threatening, though this category covers a wide spectrum of devices, from X-ray machines to some exercise equipment.

The level of scrutiny attached to Class 2 devices is much lower than Class 3. The devices do need FDA "clearance" before they can be marketed and sold, but rather than submit their products for clinical trial, the manufacturers are required instead to convince the FDA that their products are "substantially equivalent" to products that have been previously cleared by the FDA.

Substantially equivalent means that the device has the same intended use and approximate technical characteristics as an existing product.

Products that pass this clearance process may be referred to as "FDA cleared" or "FDA listed," but this is not the same as "FDA approved," which only relates to the prescription drugs and Class 3 devices that have passed PMA."

This approval method for Class 2 devices has been the subject of mounting controversy. The process is known as "510(k)" - named after its section in the law."

So it seems that class 2 devices such as those used in Gainswave treatment will never be "up for approval" but rather only need to be "cleared" to be sold in the United States. Since they are being used in medical offices I think we can assume it has been "cleared" if only for the reason that doctors would not otherwise be performing the procedures due to medical liability reasons.

Yeah. I know. That's why, when @gsoler stated that "the technology is approved by the FDA for home use", I asked where he saw this.

 

[HungCockJock]

Yeah. I know. That's why, when @gsoler stated that "the technology is approved by the FDA for home use", I asked where he saw this.

Therein lie the language mix-up I referred to earlier.

 

[HukPhin]

So I went to a Gainedwave doctor for a consultation today. He was a wacky and into all the trendy ant-aging stuff. Despite his fast-talking, multi-session sales pitch - I ponied up the $600 for 1 session. I was asked to apply this numbing cream all around my crotch - then keep my pants off and wait for the nurse. A nice looking nurse worked me all over (including the anal area) for @15 minutes. I though it was pleasant - and was surprised I did not pop a boner (not too easy with numbing agent on). I will report back after the numbness wears off.

 

[gsoler]

So I went to a Gainedwave doctor for a consultation today. He was a wacky and into all the trendy ant-aging stuff. Despite his fast-talking, multi-session sales pitch - I ponied up the $600 for 1 session. I was asked to apply this numbing cream all around my crotch - then keep my pants off and wait for the nurse. A nice looking nurse worked me all over (including the anal area) for @15 minutes. I though it was pleasant - and was surprised I did not pop a boner (not too easy with numbing agent on). I will report back after the numbness wears off.

I bought one of those devices and apply it some 3 x week. It does help with erection quality, but dont think its of much help with penis enlargement aims. At best, it helps to keep your penis in good form and function, which is good enough for me while I go on with my PE ;-)

 

[mav9x7]

So I went to a Gainedwave doctor for a consultation today. He was a wacky and into all the trendy ant-aging stuff. Despite his fast-talking, multi-session sales pitch - I ponied up the $600 for 1 session. I was asked to apply this numbing cream all around my crotch - then keep my pants off and wait for the nurse. A nice looking nurse worked me all over (including the anal area) for @15 minutes. I though it was pleasant - and was surprised I did not pop a boner (not too easy with numbing agent on). I will report back after the numbness wears off.

Keep us posted! Looking to make a visit to a local provider.

 

[Stratavos]

My surprise is that the device supposedly breaks up plaques that form in the tiny blood vessels that supply the erectile tissue of the penis. These plaques form over a lifetime, so it's odd that if the device removes them enough that they no longer restrict blood flow enough to cause ED, that they would return enough to matter in only a year and a half.

hypothetically, the plaque, similar to dental plaque, is a byproduct of diet, and happens to accumulate in the blood vessels. I'm not a doctor.

 

[Stratavos]

The GAINSWave procedure breaks up plaque formation in blood vessels and stimulates the growth of new blood vessels in the penis. This increases the blood flow to the penis and improves sexual function. In addition, the GAINSWave procedure activates the growth of new nerve tissue in the penis.

This process, called neurogenesis, enhances sensitivity in the penis. Because GAINSWave uses low-intensity sound waves and is non-invasive, it is often referred to as Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT).

and something that is probably being overlooked: this can be used no other parts of the body too. It's shockwave therapy, that happens to be being used on the pelvic area.

 

[WangerOver]

I love that Gainswave is gaining more attention here on the forums. I think in a couple years it will be much more common knowledge how effective it is.

 

[HukPhin]

Keep us posted! Looking to make a visit to a local provider.

I have held off reporting back until I have more data - I am going for a second session this week. I found the whole experience positive (so far). Not sure I have received any lasting benefits but the sensitivity and heavenly orgasms have been great. Is it six-hundred dollars a session great - still to be determined.

 

[gsoler]

It does enhances sensitivity. I used to take a long time to ejaculate, sometimes I wouldnt because had no more energy to go on. Now that is past. I can cum more easily.

 

[strongmanxaf]

It does enhances sensitivity. I used to take a long time to ejaculate, sometimes I wouldnt because had no more energy to go on. Now that is past. I can cum more easily.

I can attest that. Got 2 sessions done and having some nice results already!