Sunday, March 19, 2006

Get My Gun!

SWIMBO came home from the gym the other day and let me know the gal that helps her work out more effectively (alternately known as Frau Blucher, the sadist) sent her to get a free demonstration of the Migun Bed.

What, I asked innocently, is a Migun Bed? According to the flier given to the fetching Mrs. DocSurg, it is a thermal massage system. Sounds nice, relaxing, soothing; kind of like a hot tub with magic fingers. But wait 'til you find out the rest ---"What does thermal massage do?" -- according to the flier:

Reduces stress
Increases energy
Relieves constant aches & pains
Improves blood circulation
Ding ding ding ding! My BS detector just went off, and the meter is reading that the BS titer is critical and rising! Once you see the word "DETOXIFIES," you can bet your last bottle of ginseng that there is a more quackery to be found here than in a pond full of mallards. But here is the best part of the flier:
FDA Migun Thermal Massage System is approved by FDA as a Class II medical instrument under the 510k regulation, and can be used without a prescription.
Okey dokey. This is the kind of cr&p that gets under my skin and doesn't quit bothering me for days on end. Being a true novice when it comes to the FDA process, I did the obvious, and went to the source --- FDA Device Advice abut 510K approval process:

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.

In other words, the 510(k) approval means that a device is substantially similar to another product, so that a separate approval for a completely "new" device is not necessary. In even other words, there's nothing revolutionary about this product, since its own advertisement must be substantially equivalent to some other, already approved device ---- and there are a number of devices that provide heated massage.

But wait! It's the F-FRICKIN'-DA! That must mean some kind of sanction for this fantastique device, which, as we can all see, relies on the "5 Migun Principles:"
Chiropractic: Restores structural integrity and relieves nerve interference by restoring vertebrae alignment with its patented technology.
Far-Infrared: Increases function of tissue cells and enhances blood circulation.
Acupuncture: Stimulates specific points of the body to recharge life force and bring proper balance.
Acupressure: Temporarily blocks the circulation of Qi and the release jump starts the Qi movement to flush out the toxins.
Massage: May ease chronic pain, speed recovery from sports injuries, and make your muscles more agile.
Ding ding ding ding (see BS meter above)! Step right up folks! We've got your chiropractic, your far infrared, your acupuncture, and your acupressure quackery right here, provided by the all-important "new external 15 way jade massage heads and 2 way jade massage heads" --- of course, "According to oriental medicine, jade has always been known to have mysterious healing affects, promoting longevity, and discharging toxins from our bodies." Can't forget about the critical effects of jade, now can we?

Let's just say that I am a bit, well, jaded. Why? From the original FDA approval letter for this device, here are the indications for its use:
The intended use of the Migun Model HY-7000 Thermassage Energy Product is to
provide patients with muscle relaxation therapy by delivering heat and soothing massage.
Additionally, the infrared lamps provide topical heating for;
o temporary relief of minor muscle and joint pain, and stiffness
o the temporary relief of minor joint pain associated with arthritis
o the temporary increase in local circulation where applied
o relaxation of muscles
Well. Um, let's see. Where's the jade in all of that? The Qi? The increased function of tissue cells and enhanced blood circulation? The recharging of life force? Proper balance? The de-frickin'-toxification?!!!!! How the HEDOUBLEHOCKEYSTICKS do you get from the FDA's own approval letter to this?:
Many people suffering from the following symptoms reported varying degrees of relief after using The Migun Thermal Massage Bed:
Parkinson's disease / stroke kidney /• prostate /• diarrhea /constipation /• expansion of abdominal region /• stomach /• ulcers /• lungs /• asthma /• yellow jaundice /• heart / liver sclerosis /• fatty liver / arteriosclerosis / hypertension /• sore hands / eye diseases / deafness / headaches / cataract / tonsillitis / thyroid insufficiency / emphysema / insomnia / nervous prostration / diabetes / menstrual irregularities / loss of energy, etc.
Look, I think that this thing looks pretty relaxing and might be a soothing alternative to a massage for some folks. In practical terms, at a cost of around 2 grand, it's probably not a whole lot more effective than my late great uncle Bill's vibrating green naugahyde barcalounger. If you got the cash, and it sounds good to you, buy one. But I hope somehow, somewhere, in some dimension, people who advertise this kind of quackery -- that a massage table helps diabetes! -- find themselves not nicely laid out on a comfy massage table, but meeting up with Procrustes for all of eternity.

For them, the torture should not be the comfy chair, it should be the rack.