SEA-BAND LIMITED

Sea-Band Limited specializes in acupressure wristbands, which are designed to apply targeted pressure to specific wrist points. These devices are intended for pain relief and symptom management, particularly for conditions like motion sickness, nausea, and minor headaches. The wristbands are marketed as a non-invasive option to help alleviate these symptoms.

Sea-Band Limited operates from the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or production sites may vary.

Sea-Band Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.

Sea-Band Limited’s devices are classified as Class II (U) under FDA regulations. This classification is based on the level of risk associated with the product—Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.