All class II microcurrent devices are allowed to be marketed to physicians in the United States if they have applied for and obtained a 510(k) clearance through the FDA. The certificate means it can be used in a medical setting as well as at-home prescription-based use and is substantially equivalent to other devices. FDA has approved all microcurrent devices for sale in the category of TENS devices. 510(k) clearances for specific devices can be found on the FDA's website. From the Federal Food, Drug, and Cosmetic Act page While microcurrent is categorized alongside TENS devices, it is an entirely different and much lower level of current. The lower level of current makes it a more suitable modality of healing where the higher current of TENS is primarily muscle stimulating, with little to no inherent healing potential . In 1998 "Microcurrent treatment of myofascial pain in the head neck and face". She recorded significant improvement for the 50 patients in the sample. In the paper McMakin notes that despite the limitations included in the study , the conditions and sequential administration of fsm after other modalities were unsuccessful .
All class II microcurrent devices are allowed to be marketed to physicians in the United States if they have applied for and obtained a 510(k) clearance through the FDA. The certificate means it can be used in a medical setting and is substantially equivalent to other devices. FDA has approved all microcurrent devices for sale in the category of TENS devices. 510(k) clearances for specific devices can be found on the FDA's website. From the Federal Food, Drug, and Cosmetic Act page A 2011 study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues. This may lead to a reevaluation of FDA procedures and better oversight . In 1998 "Microcurrent treatment of myofascial pain in the head neck and face". She claimed significant improvement for the 50 patients in the sample. In the paper McMakin notes limitations included in the study : A neither average nor random sample. No systematic control group or placebo condition. Patients, physicians, and third-party expected positive outcomes. FSM was not the only treatment given to the patients .
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as well as at-home prescription-based use
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While microcurrent is categorized alongside TENS devices, it is an entirely different and much lower level of current. The lower level of current makes it a more suitable modality of healing where the higher current of TENS is primarily muscle stimulating, with little to no inherent healing potential
A 2011 study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues. This may lead to a reevaluation of FDA procedures and better oversight
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recorded
claimed
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that despite the
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, the conditions and sequential administration of fsm after other modalities were unsuccessful
: A neither average nor random sample. No systematic control group or placebo condition. Patients, physicians, and third-party expected positive outcomes. FSM was not the only treatment given to the patients