QBC — External Upper Limb Tremor Stimulator Class II
FDA product code QBC covers "External Upper Limb Tremor Stimulator", a Class II medical device regulated under 21 CFR 882.5897. Submissions are reviewed by the Neurology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBC
- Device Class
- Class II
- Regulation Number
- 882.5897
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253587 | Cala Health | Cala kIQ Plus | Mar 17, 2026 |
| K251517 | Encora | Encora X1 | Feb 5, 2026 |
| K250096 | Fasikl Incorporated | Felix NeuroAI System | Jul 1, 2025 |
| K243848 | Cala Health | Cala kIQ | Jan 16, 2025 |
| K242259 | Cala Health | Cala kIQ | Nov 22, 2024 |
| K222237 | Cala Health | Cala kIQ | Nov 22, 2022 |
| K203288 | Cala Health | Cala Trio | Oct 5, 2021 |
| K182706 | Cala Health | External upper limb tremor stimulator | Oct 25, 2018 |
| DEN170028 | Cala Health | Cala ONE | Apr 26, 2018 |