ZYTO Technologies, Inc.

FDA Regulatory Profile

ZYTO Technologies, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 3 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2120-2016, Class II) was initiated on November 23, 2015. Its most recent 510(k) clearance was granted on August 30, 2011.

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
3
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2120-2016Class IIThe ZYTO Tower is the input device to program the software with various virtual items.November 23, 2015
Z-2121-2016Class IIThe ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response meNovember 23, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K111308ZYTO HAND CRADLEAugust 30, 2011