Cala kIQ
The Cala kIQ band positions reusable stimulation electrodes against the wrist. It connects to a wearable stimulator that delivers transcutaneous afferent patterned stimulation to the median…
The Cala kIQ band positions reusable stimulation electrodes against the wrist. It connects to a wearable stimulator that delivers transcutaneous afferent patterned stimulation to the median and radial nerves. The filed medium band is one size option.
The detachable band is one component of a system that also includes the stimulator and a separate base station. The base station charges the wearable device and transfers data. The system is operated by the patient at home after initial calibration.
Listed Item
Cala kIQ Band, Medium
Electrodes and Intended Use
The band has six electrodes made from silicone with a carbon-nanotube dispersion. Its elastic material includes polyester and spandex. Stimulation is intended for temporary relief of hand tremor in adults with essential tremor or qualifying postural and kinetic hand-tremor symptoms of Parkinson’s disease.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fasikl Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
Record
| Listed by | Cala Health, Inc., United States |
|---|---|
| FDA product code | QBC |
| Device type | External Upper Limb Tremor Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5897 |
| Establishment | Manufacturer |
| 510(k) | K253587 |
| Record published | 2025-03-24 |
| Record revised | 2025-01-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 90 % RH; Storage environment atmospheric pressure 70 to 101 KiloPascal; Storage environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TLA-20005 | In distribution | |
| TLA-3273 | In distribution | |
| TLA-3269 | In distribution | |
| TLA-20007 | In distribution | |
| TLA-3268 | In distribution | |
| TLA-3270 | In distribution | |
| TLA-20012 | In distribution | |
| TLA-20011 | In distribution | |
| TLA-20010 | In distribution | |
| TLA-20006 | In distribution | |
| TLA-3272 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cala Trio | Cala Health, Inc. | 21 |
| Felix NeuroAI | Fasikl Incorporated | 21 |
| Cala kIQ Plus | Cala Health, Inc. | 2 |
| Cala Health | Cala Health, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253587 | 2026-03-17 |
| K243848 | 2025-01-16 |
| K242259 | 2024-11-22 |
| K222237 | 2022-11-22 |
| K203288 | 2021-10-05 |
| K182706 | 2018-10-25 |
| DEN170028 | 2018-04-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.