MNE — Orthosis, Moldable, Supportive, Skin Protective Class I

FDA Device Classification

FDA product code MNE covers "Orthosis, Moldable, Supportive, Skin Protective", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.