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  • massage tools

    My physical therapist wants me to make some tools out of stainless for use in deep tissue massage. There are various tools available for this technique but they are very expensive. They are simple designs made from plate that is .375 or .500 thick cut in various shapes with large radii for grinding on sore muscles. Most are made from anodized aluminum. He would like them made from stainless with highly polished sides.

    I have taken a look at the various grades of stainless and would like to know what grade is typically used in the medical field. We are looking at what grade would be most resistance to corrosion. He washes his tools in a bleach mixture or alcohol. I am leaning toward 316 or 416..

    Does that seem appropriate? There are no concerns with strength or needs for weldability. They are simply shapes used for massage.

    I plan to cut the shapes out on my plasma table and then radius the edges on my disk and belt sanders...then buff to polish.

    What says you?

    Cheers
    Mac.

  • #2
    I've been involved with a midical device manufacturer in the past, 17-4 PH is an alloy exclusively used in medical devices. there are very few materials the FDA permits in medical equipment. Also a lot of paperwork is suppose to happen. It you google GMP (good manufacturing practices) you'd get a feel for what is supposr to go into it. Keeping this project off the radar might be wise.


    Hoof

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    • #3
      Just because something is used in "the medical field" doesn't mean it's necessarily a Medical Device. The definition is very specific: http://www.fda.gov/MedicalDevices/De.../ucm051512.htm and I don't think the item he's building qualifies.

      In the event that somehow this does qualify as a Device, then the last thing I'd do is "run under the radar." If you can't afford to submit a 510(k) Premarket Approval request, then just don't do it. Having the FDA come after you is no laughing matter. Not as bad as the IRS, but bad enough!


      Originally posted by hoof
      I've been involved with a midical device manufacturer in the past, 17-4 PH is an alloy exclusively used in medical devices. there are very few materials the FDA permits in medical equipment. Also a lot of paperwork is suppose to happen. It you google GMP (good manufacturing practices) you'd get a feel for what is supposr to go into it. Keeping this project off the radar might be wise.


      Hoof

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      • #4
        Not trying to do the wet towel thing here but make sure you don't get your tit in a ringer over any patents that may exist.
        - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
        Thank you to our families of soldiers, many of whom have given so much more then the rest of us for the Freedom we enjoy.

        It is true, there is nothing free about freedom, don't be so quick to give it away.

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        • #5
          I believe if you wanted to keep it 'off the radar', id highly recommend you do NOT sell 'massage tools' to this person.. However, some highly polished stainless steel paperweights or doorstops, Who would'nt want one!
          Play Brutal Nature, Black Moons free to play highly realistic voxel sandbox game.

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          • #6
            Originally posted by motorcyclemac
            ...grinding on sore muscles...
            Ummm...OW!!!

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            • #7
              Ah...paper weights. That would work. I am not sure that they would be a regulated device. That is something to check into. Thanks.

              This is not really in my grand scheme of things. I am a machinist and primarily a gunsmith. He knows I work with metal and dropped the question if I could make the tools.

              He has one that he bought. It is about 4" x 4" with a 3" inch radius on one side an a 1.5 inch hole in the middle to put your finger or thumb through to hold it. All the edges are rounded over to prevent scratching the skin. It is simply .375 aluminum plate that has been anodized a gold color. He paid $130 for a piece of pretty aluminum scrap. He would like to have 1 for each table at his office. We talked about making them from stainless as I didn't want to send them out for anodizing. It is kind of a silly tool.. It is simply for rubbing over tight muscles to "strip" them and forceably relax them. They put somthing like KY lover's lube on your skin and grind away at the sore spots. A glass beer coaster or a smooth rock would do the same thing.

              They just have to be smooth such that they don't scratch...and close pore so that they don't permit nasty dead skin to be retained on the surface. They must be polished such that they can be cleaned fully with bleach or alcohol. Any material that fits that description would work really.

              Cheers
              Mac.

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              • #8
                Originally posted by motorcyclemac
                My physical therapist wants me to make some tools out of stainless for use in deep tissue massage.
                316, 316L, and 316LVM (increasing purity in that order) are commonly used in medical applications.

                Sterilizing and high level disinfecting methods can be hard on materials, including metal. 316 family are pretty good in this regard. Also have good biocompatability. Plain 316 would probably be sufficient in this application, with a smooth and nonporous finish. The issue of sterilization/disinfection should not be taken lightly. MRSA, for example, is a big problem these days.

                HDPE is another material which might be suitable.

                The definition of "medical device" is so broad as to probably include massage devices. However, the FDA does not usually seem to concern itself with massage devices. Some exceptions are devices for which medical claims are made outside the half a dozen or so allowed by the FDA, electronic nerve/muscle stimulators marketed as massage devices, and a vibrator incorporating infrared heat. I suspect you might also be exempt from regulatory requiriements under CFR 807.85a(2) in this particular case since the device is being made for a specific medical practitioner at their instigation and not marketed to medical practicioners or consumers in general.
                http://www.accessdata.fda.gov/script...21:8.0.1.1.5.5

                Electric Therapeutic Massagers and vibrators not incorporating a pressure cuff or lamp (which are covered under separate categories) are exempt from premarket authorization, subject to some limitations:
                http://www.accessdata.fda.gov/script...fm?fr=890.5660
                http://www.accessdata.fda.gov/script...fm?fr=890.5975
                There is one passive pressure applying device listed, the source of pressure not coming from the therapists hands:
                http://www.accessdata.fda.gov/script...fm?fr=890.5765

                The device in question is a passive device which basically functions as an extension of the therapist's hands. A rolling pin, dowel, rock, spoon, ball, marble, etc. could also be used as an extension of the hands.

                IANAL, etc.

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