ABOUT the J5 Myomonitor TENS FDA 510K Status and Classification

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The J5 Myomonitor, which is made by Myotronics out of Kent, Washington is an FDA approved unit specifically for dental use and application.  It is valuable to doctors and patients. It comes with a full one year warranty on parts and labor.

J5 Myomonitor TENS - Clayton A. Chan, D.D.S. FDA Dental Approved

The FDA’s 510K clearance number for the J5 Myomonitor TENS is K031998 and can find the exact wording for which the device is approved on the last page of the 4-page document (June 2003) in the attachment listed here;

https://www.accessdata.fda.gov/cdrh_docs/pdf3/k031998.pdf

The J5 TENS is FDA approved to treat TMJ dysfunction and pain associated with TMJD as well as increase blood circulation, relax muscles, increase range of motion for the jaw and, most importantly, to take occlusal registrations, ie. bites (for the purpose of creating what dentists fabricate for their patients, namely, functional orthotic appliances).

Intended Use as Per FDA Classification and Approval of J5 Myomonitor TENS:

  • Used to relieve symptoms associated with muscle spasm,
  • To treat temporomandibular joint (TMJ) dysfunction and associated pain, 
  • To relax muscles and
  • Establish a physiologic occlusion,
  • To take occlusal registrations,
  • To take denture impressions,
  • To increase local blood circulation and to increase or maintain mandibular
    range of motion.

Using similar non FDA approved medical TENS devices contrary to their instructions and intended function in dentistry to treat TMD, relax masticatory muscles, establishing physiologic occlusion and or taking bite registration will likely nullify a warranty which is why OC trained dentists adhere to the Myotronics-Noromed, Inc. company recommendations and FDA indended use for approval and classification.

The J5 Myomonitor TENS is also classified for dental use contrary to previous statements made about other TENS units being used for medical purposes.

The FDA watches carefully to ensure the safety of medical machinery as well as what is touted by the manufacturer about the performance of that machinery.

– Edited and compiled by Dr. Bruce Greenstein, Miami, Florida (GNM trained)

OC GNM Trained Dentists Use FDA Approved Instrumentation as Indicated for Dental Use and Application.

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To Read More: PHYSIOLOGIC REST – A Key to Effective Diagnosis and Treatment

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ABOUT the J5 Myomonitor TENS FDA 510K Status and Classification