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Wello Inc. was warned for manufacturing the welloStationX medical device with misbranded labeling in violation of FDA regulations. The company failed to include a required unique device identifier (UDI) on device labels in both plain-text and machine-readable formats as mandated by 21 CFR 801.20(a) and related regulations, making the critical identification information not prominently displayed or easily readable to consumers. The violations were identified during an FDA inspection conducted at the company's Addison, Texas facility in June 2023.