QBC — External Upper Limb Tremor Stimulator Class II
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 |
|---|---|---|---|
| K251517 | encora | Encora X1 | February 5, 2026 |
| K250096 | fasikl incorporated | Felix NeuroAI System | July 1, 2025 |
| K243848 | cala health | Cala kIQ | January 16, 2025 |
| K242259 | cala health | Cala kIQ | November 22, 2024 |
| K222237 | cala health | Cala kIQ | November 22, 2022 |
| K203288 | cala health | Cala Trio | October 5, 2021 |
| K182706 | cala health | External upper limb tremor stimulator | October 25, 2018 |
| DEN170028 | cala health | Cala ONE | April 26, 2018 |