This should include an identification of similar products, design considerations, energy delivered by the device, and a description of the operation principles of the device. The manufacturer (or importer) is to provide a discussion indicating the similarity and/or difference of the device to legally marketed comparable products which are used for GSR device, accompanied by data to support the statement. The intended use must be clearly stated and must be consistent with the “indications” specified in the product labeling. Copies of all programmable displays must be provided. This must include pictures or drawings of the device showing all controls, indicators, displays and connections. The file must include a complete and precise description of the device including a description of the functional characteristics, the controls, and all data provided to the user.
#GALVANIC SKIN RESPONSE MEASUREMENT DEVICE SKIN#
Its purpose is to provide specific applicable to 510(k)s that claim equivalence to Galvanic Skin Response measurement (GSR) devices. This guidance is to be used in conjunction with the Division of Cardiovascular, Respiratory and Neurological Devices “Draft Guidance for Format and Content for Premarket Notification 510(k)”, which provides general guidance for preparing a “510(k)” premarket notification. Rockville, MD 20850 Neurological Devices Branchĭivision of Cardiovascular, Respiratory and Neurological DevicesĪugust 1994 Skin Response Measurement Devices – Draft Guidance For 510(K) Content INTRODUCTION DEPARTMENT OF HEALTH AND HUMAN SERVICESĬenter for Devices and Radiological Health With most quack devices, one electrode is a probe that the operator touches to patient’s skin with variable pressure that influences what the device measures. The electrodes of legitimate biofeedback devices are temporarily affixed to the patient’s skin so that the pressure against the skin remains constant. It appears to have been issued to prevent manufacturers of quack diagnostic and treatment devices from getting 510(k) clearance as “biofeedback” devices, which they are not. The document below, which is slightly reformatted from the original to make it more readable, provides manufacturers with guidance about what is needed to get FDA “510(k)” clearance for marketing. GSR devices have legitimate use in relaxation treatment but no legitimate use for diagnosis or to influence any disease process. (Electrical current passes readily through water, perspiration will lower the GSR). The main factor that influences the GSR is perspiration. These devices-commonly referred to as galvanic skin response or GSR devices-produce a tiny current and measure how well the current passes from the skin back to the device. In 1994, the FDA issued a document to guide the approval process for devices used to measure skin resistance. The patient may ultimately learn to control the body function subconsciously without the machine. The patient is instructed to relax so that the signals decrease to a desirable level. In biofeedback, the patient is wired to a device that continuously signals the heart rate, degree of muscle contraction, skin resistance, or other indicator. I had no idea that the galvanic skin response was a biofeedback, but this article totally explained how it worked and made the whole topic very clear - in an interesting manner.Biofeedback is a relaxation technique that can help people learn to control various autonomic functions. It can take the most random sounding topic and make it interesting. I've always been interested in the whole biofeedback thing, and GSR biofeedback is an especial pet topic of mine.ĭo you have any idea bout how one would go about making a basic galvanic skin response device, or if it's even possible to do at home? I would be really curious to try this out as a weekend project. Is there any way to jerry-rig some of that galvanic skin response equipment at home? That sounds like it could be a really fun project. I know that some people can train themselves to beat the lie detector test, but it's not like you can retrain your skin, right? So how does that work? I wonder who first figured out the connection between the GSR and lying? I bet his colleagues looked at him like he was crazy when he first proposed that project!īut I do have one question - if the whole GSR thing works, then how can people beta a galvanic skin response monitor in a lie detector test? This is such a cool article! I had some vague idea that the skin could conduct electricity, but I had no idea that you could actually use the galvanic skin response as biofeedback. It's pretty simple, you just need an arduino board. December 5, Charlie 89, yeah you could make your own GSR at home.