Home GUDID 00851749007474 Cala kIQ
Primary DI 00851749007474
Brand Cala kIQ
Company CALA HEALTH, INC.
Model TLA-20007
Device description Cala kIQ Band, Large
Published 2025-03-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QBC External Upper Limb Tremor Stimulator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBC External Upper Limb Tremor Stimulator Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851749007474 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851749007474 00851749007474 851749007474 0851749007474
GMDN Terms# Term, Definition table Term Definition Tremor-suppression transcutaneous electrical stimulation wristband An electrically-powered device designed to be worn on the wrist of an adult patient with hand tremors [e.g., due to Parkinson’s disease, essential tremor (ET)] to: 1) collect motion data (e.g., tremor frequency); and 2) apply patient-specific electrical stimuli to the median and/or radial nerve(s) through the skin (transcutaneously) to help suppress or cancel the tremors. It is a wristwatch-like device that includes a motion sensor, pulse generator and electrodes; the technology may be referred to as transcutaneous afferent patterned stimulation (TAPS). This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 101 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 078877556 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00851749007528 Cala kIQ Plus CALA HEALTH, INC. QBC 2026-05-01 00851749007535 Cala kIQ Plus CALA HEALTH, INC. QBC 2026-05-01 00851749007542 Cala kIQ CALA HEALTH, INC. QBC 2026-05-01 00851749007559 Cala kIQ CALA HEALTH, INC. QBC 2026-05-01 00851749007566 Cala kIQ CALA HEALTH, INC. QBC 2026-05-01 00850077317002 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317019 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317026 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317033 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317040 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317118 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317125 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317132 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317149 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317156 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317163 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317170 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317187 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317194 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317200 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317217 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317224 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317231 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317248 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317255 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00850077317262 Felix NeuroAI Fasikl Incorporated QBC 2025-08-13 00851749007481 Cala kIQ CALA HEALTH, INC. QBC 2025-03-24 00851749007498 Cala kIQ CALA HEALTH, INC. QBC 2025-03-24 00851749007412 Cala kIQ CALA HEALTH, INC. QBC 2023-06-12 00851749007429 Cala kIQ CALA HEALTH, INC. QBC 2023-06-12
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