21
Oct
2009

Cl Il Neuro Kinetics SW

0

Company:Neuro Kinetics.
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009

REASON
Marketed without a 510k or PMA submission to include the normative data display.

RECALLING FIRM/MANUFACTURER
Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
72 units

DISTRIBUTION
Nationwide, Korea, United Kingdom and Spain

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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