510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ZYTO Technologies, Inc.

Lehi, UT, US

ZYTO Technologies, Inc. appears in FDA device records in Lehi, UT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for ZYTO Technologies, Inc. in 2011.

Clearances by year, as a table
510(k) clearance decisions for ZYTO Technologies, Inc., by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K111308ZYTO HAND CRADLEGZOSubstantially Equivalent

Registered establishments

FDA registered establishments for ZYTO Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30084932383008493238ZYTO Technologies, Inc.1401 N. Thanksgiving Way, Lehi, UT 84048 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2121-2016The 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).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.Class IITerminated
Z-2120-2016The ZYTO Tower is the input device to program the software with various virtual items.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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain