title: Medical devices; physical medicine devices; classification of the nonpowered lower extremity pressure wrap. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D058128:Compression Bandages / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D035002:Lower Extremity; D062307:Medical Device Legislation; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence