Cala kIQ

Basic Information

• Brand Name: Cala kIQ
• Primary DI: 00851749007429
• Version / Model: TLA-3269
• Company Name: CALA HEALTH, INC.
• Labeler DUNS: 078877556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: 4d742fb1-5650-445c-935f-85c6c52e11f3

Device Description

Base Station

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBC	External Upper Limb Tremor Stimulator	Neurology	882.5897	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64948	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851749007429	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K222237	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 101 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity