Jul

2016

Cl II ZYTO Select and ZYTO Elite software progra

Company: ZYTO Technologies Inc.
Date of Enforcement Report 7/13/2016
Class lI:

PRODUCT

The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
Recall Number Z-2121-2016

REASON
ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

RECALLING FIRM/MANUFACTURER
ZYTO Technologies Inc.,Lindon, UT on 11/23/2015 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1252 total

DISTRIBUTION
Nationwide. Canadian and other foreign consignees. No VA/govt/military.

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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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Cl II ZYTO Select and ZYTO Elite software progra

Amy Sellers

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