May

2005

Electrologic of America Inc.

Recipient: Electrologic of America Inc.
Product: Electrical muscle stimulator stationary bicycles
Date: 5/9/05

Failure to verify, validate and create a design history file when design changes were made to the StimMaster electrical muscle stimulation stationary bicycle [21 CFR 820.30(i) and (j)]. Engineering Change Notice, dated 11/1/02, states that four inches were removed from the front of the seat, a keypad was added and the buttons were removed, the riding angles were adjusted, and the software was upgraded. There is no verification and validation testing, including software validation, documented for these changes; and a design history file which includes inputs, outputs, verification, validation, design reviews, and design transfer documents was not created.

FDA District: Cincinnati District Office

About the author

Amy Sellers

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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Electrologic of America Inc.

Amy Sellers

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