QBC
- Product code
- QBC
- Device name
- External Upper Limb Tremor Stimulator
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5897
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
FDA classification definition
An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253587 | 2026-03-17 | Cala Health, Inc. | Cala kIQ Plus | |
| K251517 | 2026-02-05 | Encora, Inc. | Encora X1 | |
| K250096 | 2025-07-01 | Fasikl Incorporated | Felix NeuroAI System | |
| K243848 | 2025-01-16 | Cala Health, Inc. | Cala kIQ | |
| K242259 | 2024-11-22 | Cala Health, Inc. | Cala kIQ | FDA |
Official FDA classification page: QBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).