FDA.reportPublic FDA data

Cala kIQ

Primary DI
00851749007443
Brand
Cala kIQ
Company
CALA HEALTH, INC.
Model
TLA-3270
Device description
Cala kIQ Band, Medium
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBCExternal Upper Limb Tremor Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBCExternal Upper Limb Tremor StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222237000Cala kIQCala Health, Inc.2022-11-22QBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851749007443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851749007443008517490074438517490074430851749007443

GMDN Terms#

Term, Definition table
TermDefinition
Tremor-suppression transcutaneous electrical stimulation wristbandAn 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
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal101 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-699-1009customercare@calahealth.com

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851749007528Cala kIQ PlusTLA-200082026-05-01
00851749007535Cala kIQ PlusTLA-200092026-05-01
00851749007542Cala kIQTLA-200102026-05-01
00851749007559Cala kIQTLA-200112026-05-01
00851749007566Cala kIQ TLA-200122026-05-01
00851749007474Cala kIQTLA-200072025-03-24
00851749007481Cala kIQTLA-200062025-03-24
00851749007498Cala kIQTLA-200052025-03-24
00851749007412Cala kIQTLA-32682023-06-12
00851749007429Cala kIQTLA-32692023-06-12
00851749007436Cala kIQTLA-32722023-06-12
00851749007450Cala kIQTLA-32732023-06-12
00851749007283Cala TrioTLA-32622021-09-23
00851749007290Cala TrioTLA-32632021-09-23
00851749007306Cala TrioTLA-32642021-09-23
00851749007313Cala TrioTLA-32652021-09-23
00851749007320Cala TrioTLA-32662021-09-23
00851749007337Cala TrioTLA-32672021-09-23
00851749007276Cala TrioTLA-32062021-06-29
00851749007214Cala TrioTLA-31942021-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851749007528Cala kIQ PlusCALA HEALTH, INC.QBC2026-05-01
00851749007535Cala kIQ PlusCALA HEALTH, INC.QBC2026-05-01
00851749007542Cala kIQCALA HEALTH, INC.QBC2026-05-01
00851749007559Cala kIQCALA HEALTH, INC.QBC2026-05-01
00851749007566Cala kIQ CALA HEALTH, INC.QBC2026-05-01
00850077317002Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317019Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317026Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317033Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317040Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317118Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317125Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317132Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317149Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317156Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317163Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317170Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317187Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317194Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317200Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317217Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317224Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317231Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317248Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317255Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317262Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00851749007474Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007481Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007498Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007412Cala kIQCALA HEALTH, INC.QBC2023-06-12