Identifiers
- 510(k) Number
- DEN170028 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
- DENG FDA 510(k)
The Cala ONE is an External Upper Limb Tremor Stimulator, classified as a Class II device under FDA regulation 882.5897. It is designed to provide targeted stimulation to reduce tremor symptoms in the upper limbs, specifically targeting conditions such as essential tremor. This non-invasive device employs external stimulation techniques to modulate neural activity, aiming to improve motor control and reduce involuntary movements. Its primary function aligns with neuromodulation therapies for neurological disorders, particularly those affecting tremor management.
The Cala ONE is supplied as a reusable device and is intended for use in clinical settings, including neurology departments. It is not sterile and is not intended for MRI environments, as its materials and components may not be MRI-safe. The device is available in multiple configurations, as indicated by the registration numbers 3031696786, 3011628389, 3043526479, and 3038912617, which correspond to distinct product variants. Storage instructions are not specified in the regulatory data, but proper handling and maintenance are implied to ensure functionality and safety. The device holds FDA De Novo clearance (DEN170028) and is regulated under the product code QBC.
Frequently asked questions
What conditions is the Cala ONE specifically designed to help manage, and how does it work?
The Cala ONE is designed to reduce tremor symptoms in the upper limbs, particularly for conditions like essential tremor. It achieves this through external neuromodulation—non-invasive stimulation that targets neural activity to improve motor control and minimize involuntary movements. It’s not intended for lower limb tremors or other neurological conditions.
Is the Cala ONE meant for single-use or repeated clinical sessions, and how should it be maintained?
The Cala ONE is a reusable device intended for use in clinical settings like neurology departments. While specific storage instructions aren’t detailed in the regulatory data, proper handling and maintenance are implied to ensure functionality and safety over multiple uses. It is not sterile, so cleaning protocols should follow manufacturer guidelines to prevent contamination.
Are there different versions of the Cala ONE, and how can I identify which variant I need?
Yes, the Cala ONE comes in multiple configurations, each corresponding to distinct registration numbers: 3031696786, 3011628389, 3043526479, and 3038912617. These variants likely differ in specifications or features, so selecting the correct one depends on clinical needs and compatibility with patient requirements. Confirm the exact variant with Cala Health or your supplier.
Can the Cala ONE be used in an MRI environment, and why or why not?
No, the Cala ONE is not intended for MRI environments. The regulatory data explicitly states its materials and components may not be MRI-safe, which could pose risks during imaging procedures. Always verify device compatibility with MRI protocols before use.
What regulatory pathway does the Cala ONE follow, and what does that mean for its use?
The Cala ONE received FDA De Novo clearance under the product code QBC, meaning it was reviewed as a novel Class II device through a specialized pathway (DEN170028). This clearance confirms it meets FDA safety and effectiveness standards for external upper limb tremor stimulation. Clinicians can rely on this approval for clinical use, though adherence to manufacturer instructions remains critical.
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: Study Details | NCT03152136 | A Pilot Study of the Cala ONE Device for ..., Cala One FDA De Novo DEN170028 Cala Health, Inc., Cala ONE Device in Essential Tremor - Clinical Trials Registry - ICH GCP, PDF De Novo Classification Request for Cala One, Cala ONE Device in Essential Tremor - Clinical Trials Registry - ICH GCP
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN170028 | Class II | Active |
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Manufacturer
- Manufacturer
- Cala Health, Inc.
Sources (1)
- FDA 510(k) DEN170028 24 fields · synced Sep 20, 2026