Identifiers
- 510(k) Number
- K242259 FDA 510(k)
- FDA Product Code
- QBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5897 FDA 510(k)
- Regulation Number
- 882.5897 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cala kIQ is an external upper limb tremor stimulator designed to provide neuromodulation for hand tremor relief. This wearable device delivers patterned stimulation to the wrist to ease symptoms in the treated hand.
This prescription device is worn like a wristwatch and utilizes noninvasive technology for tremor control. It has received FDA 510(k) clearance as a Class 2 medical device under the neurology specialty.
Frequently asked questions
What is the primary function of the Cala kIQ?
The Cala kIQ is an external upper limb tremor stimulator designed to provide neuromodulation for the relief of hand tremors. It functions by delivering patterned stimulation to the wrist to help ease symptoms in the treated hand.
How is the Cala kIQ worn and used?
The device is designed to be worn like a wristwatch. It utilizes noninvasive technology to deliver its therapeutic stimulation directly to the wrist area to manage tremor symptoms.
Is the Cala kIQ available for general purchase?
No, the Cala kIQ is a prescription device. It has received FDA 510(k) clearance as a Class 2 medical device under the neurology specialty, meaning it must be obtained through a healthcare provider.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA approves wearable sensor for tremor control in Parkinson's, Cala kIQ System by Cala Health — Product Research | aVenture, Cala Health, Inc. FDA 510 (k) Products - Latest 2026, Cala Health Wins 2026 MedTech Breakthrough Award for Best New Neurology ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242259 | Class II | Active |
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Manufacturer
- Manufacturer
- Cala Health, Inc.
Sources (1)
- FDA 510(k) K242259 24 fields · synced Sep 27, 2026