18
Aug
2003

Bioflex Inc.

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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