COMPANY
Cala Health
Timeline
- FDA FDA 510(k) clearance: Cala kIQ Plus — K253587, Mar 17, 2026. Applicant at approval: Cala Health, Inc. source ↗
- FDA FDA 510(k) clearance: Cala kIQ — K243848, Jan 16, 2025. Applicant at approval: Cala Health, Inc. source ↗
- FDA FDA 510(k) clearance: Cala kIQ — K242259, Nov 22, 2024. Applicant at approval: Cala Health, Inc. source ↗
- Trial start Not phased (device or behavioral study): Peripheral Nerve Stimulation Therapy for Atrial Fibrillation source ↗
- Trial start Not phased (device or behavioral study): Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis source ↗
- Trial start Not phased (device or behavioral study): Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands source ↗
- Trial start Not phased (device or behavioral study): RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor source ↗
- Trial start Not phased (device or behavioral study): Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor source ↗
- Trial start Not phased (device or behavioral study): Prospective Study for Symptomatic Relief of ET With Cala Therapy source ↗
- Trial start Not phased (device or behavioral study): A Pilot Study of the Cala ONE Device for Essential Tremor source ↗
- Trial start Not phased (device or behavioral study): Cala ONE Device for Essential Tremor source ↗
Clinical trials (lead sponsor) 8
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05540626 | RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor | Not phased (device or behavioral study) | Completed | Apr 8, 2021 | Mar 1, 2024 (actual) |
| NCT05012579 | Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor | Not phased (device or behavioral study) | Completed | Nov 11, 2020 | Mar 12, 2021 (actual) |
| NCT03597100 | Prospective Study for Symptomatic Relief of ET With Cala Therapy | Not phased (device or behavioral study) | Completed | Dec 14, 2018 | May 29, 2019 (actual) |
| NCT02629614 | Cala ONE Device for Essential Tremor | Not phased (device or behavioral study) | Completed | 2016-04 | 2016-11 (actual) |
| NCT05662059 | Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Jan 12, 2023 | Dec 30, 2023 (estimated) |
| NCT05653583 | Peripheral Nerve Stimulation Therapy for Atrial Fibrillation | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | 2023-03 | 2023-12 (estimated) |
| NCT05480215 | Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands | Not phased (device or behavioral study) | Completed | Oct 7, 2021 | Dec 16, 2021 (actual) |
| NCT03152136 | A Pilot Study of the Cala ONE Device for Essential Tremor | Not phased (device or behavioral study) | Completed | Jul 26, 2017 | Mar 8, 2018 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Cala kIQ Plus — K253587, Mar 17, 2026. Applicant at approval: Cala Health, Inc. source ↗
- FDA 510(k) clearance: Cala kIQ — K243848, Jan 16, 2025. Applicant at approval: Cala Health, Inc. source ↗
- FDA 510(k) clearance: Cala kIQ — K242259, Nov 22, 2024. Applicant at approval: Cala Health, Inc. source ↗
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