QBC
9 FDA 510(k) clearances · Product code
120 daysmedian time to decision
344 days90th percentile
9clearances measured
FDA profile
- Official device name
- External Upper Limb Tremor Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5897
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cala kIQ Plus (K253587) | Cala Health, Inc. | 2026-03-17 |
| Encora X1 (K251517) | Encora, Inc. | 2026-02-05 |
| Felix NeuroAI System (K250096) | Fasikl Incorporated | 2025-07-01 |
| Cala kIQ (K243848) | Cala Health, Inc. | 2025-01-16 |
| Cala kIQ (K242259) | Cala Health, Inc. | 2024-11-22 |
| Cala kIQ (K222237) | Cala Health, Inc. | 2022-11-22 |
| Cala Trio (K203288) | Cala Health, Inc. | 2021-10-05 |
| External upper limb tremor stimulator (K182706) | Cala Health, Inc. | 2018-10-25 |
| Cala ONE (DEN170028) | Cala Health, Inc. | 2018-04-26 |
Track QBC automatically
Every clearance here is in the API, with alerts when new ones post.