There is little doubt - transcutaneous electrical nerve
stimulators (TENS) relieves the sensation of pain. The
gate control theory of pain proposed in 1965 by Dr.
Ronald Melzack and Dr. Patrick Wall explain that
selective stimulation of specific nerve fibers block or close
the gate on signals carrying a pain impulse to the brain.
Compliance Consultants has submitted many 510(k)s with TENS devices having "extended" claims. In most cases, the sponsors desire claims not equal to their predicates. These non-significant risk devices are ideally suited to clinical studies using 60-90 patients for very narrow claims supported with Bayesian Statistics.
We have assisted in the design and the 510K application for many TENS devices. Regulation Number 21 CFR 882.5890, Product Code: Product Code: GZJ, NYN, NUH, NYW, OCF. NHI, NFO. TENS devices are prescription only for pain and over the counter for aesthetic purposes.
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm199265.htm
Compliance Consultants has submitted many 510(k)s with TENS devices having "extended" claims. In most cases, the sponsors desire claims not equal to their predicates. These non-significant risk devices are ideally suited to clinical studies using 60-90 patients for very narrow claims supported with Bayesian Statistics.
We have assisted in the design and the 510K application for many TENS devices. Regulation Number 21 CFR 882.5890, Product Code: Product Code: GZJ, NYN, NUH, NYW, OCF. NHI, NFO. TENS devices are prescription only for pain and over the counter for aesthetic purposes.
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm199265.htm
