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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