Facility

ZYTO Technologies, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008493238
Establishment type	Manufacture Medical Device
Location	1401 N. Thanksgiving Way Lehi, UT, US 84048
Registration status	Active · expires 2026
Parent company	ZYTO Technologies, Inc. (owner-operator 10043910)
Brand names	ZYTO Hand Cradle

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Device, Galvanic Skin Response Measurement
Product code GZO (opens in a new tab) · Class II · Neurology · 21 CFR 882.1540

Recalls & enforcement

Class IITerminated2015-11-23
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.

FDA inspections (2)

OAI2022-12-13
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-04-24
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2023-06-21
Warning Letter (opens in a new tab) · Pleasant Grove Utah

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by ZYTO Technologies, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ZYTO Technologies, Inc. (FEI 3008493238) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008493238-zyto-technologies-inc/

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