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Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)
Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot
Software of modular driver may incorrectly report patient results as Quality Control Results