Tutamen Self Adhesive Electrodes

The Tutamen Self-Adhesive Electrodes are non-sterile, flexible electrode pads designed for single-patient, single-application use. They transmit electrical stimulation current to the patient's skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation) applications. The device is available in two shapes: round (Ø50 mm) and rectangle (50×100 mm), with a fixed lead wire terminated in a 2 mm pigtail pin connector.

The device uses conductive carbon cloth laminated with biocompatible conductive hydrogel (Hydrogel MH051, 1.8 mm thick) and non-woven fabric backing. It has 1 kHz impedance of 509–599 Ω and a maximum current density of 0.51 mA/cm² for the round electrode. The hydrogel pH is 5.8±0.4. Key differences from the predicate include single-application use (vs. multiple applications), two geometries offered (vs. six), a 2 mm pigtail pin connector, and thicker hydrogel (1.8 mm vs. 0.89 mm).

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation) for biocompatibility evaluation. Non-clinical bench testing included electrode impedance testing, adhesive strength and electrode integrity testing, and 2-year real-time shelf-life aging studies.