Company: Bioflex Inc..Product: Electrical stimulation devices Date: 8/18/03 Failure to establish procedures to ensure that equipment is routinely calibrated, checked and maintained. [21 CFR 820.72(a)] For example, the…meter used to test the electrodes on the BioShort electronic stimulation garments has not been calibrated and there is no calibration program for this meter. Failure to establish...Read More