Does the Tennant Biomodulator® PLUS have FDA Approval / Acceptance?
A. The Tennant Biomodulator® PLUS is a Biofeedback-controlled electro-stimulator. Regulated by the United States Food and Drug Administration, under 21 CFR 882.5890, Transcutaneous electrical nerve stimulator for pain relief, Product Code GZJ, Class II medical device. Indications for use: for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. The FDA requires that the Tennant Biomodulator® PLUS be used by or upon the recommendation of a licensed health practitioner and a written prescription.
