FDA Statement
The Tennant Biomodulator® and certain accessory electrodes are FDA listed by its distributor or manufacturer in these categories:
21 CFR 882.5890 – Neurology transcutaneous electrical nerve stimulator for pain relief
21 CFR 882.5050 – Neurology biofeedback device Indications for use: Symptomatic relief and management of chronic, intractable pain Adjunctive treatment in the management of post-traumatic surgical and post-traumatic pain Relaxation training and muscle relaxation |