Cala kIQ

GUDID 00851749007436

Cala kIQ Band, Small

CALA HEALTH, INC.

Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband Tremor-suppression transcutaneous electrical stimulation wristband
Primary Device ID00851749007436
NIH Device Record Key22c3a639-afbb-448c-8525-0d05d3846d41
Commercial Distribution StatusIn Commercial Distribution
Brand NameCala kIQ
Version Model NumberTLA-3272
Company DUNS078877556
Company NameCALA HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com
Phone888-699-1009
Emailcustomercare@calahealth.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100851749007436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBCExternal Upper Limb Tremor Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

On-Brand Devices [Cala kIQ]

00851749007450Cala kIQ Band, Large
00851749007443Cala kIQ Band, Medium
00851749007436Cala kIQ Band, Small
00851749007429Base Station
00851749007412Stimulator

Trademark Results [Cala kIQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALA KIQ
CALA KIQ
97111550 not registered Live/Pending
Cala Health, Inc.
2021-11-05

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