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 a Device Master Record for the electronic stimulations garments. [21 CFR 820.181]

FDA District: Cincinnati District Office