FDA product code QBC: External Upper Limb Tremor Stimulator
QBC is the FDA product code for external upper limb tremor stimulator. It is a Class II device, regulated under 21 CFR 882.5897 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under QBC, 6 in the last five years, from 3 different applicants. The average 510(k) review took 147 days (median 120); 135 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | External Upper Limb Tremor Stimulator |
| Device class | Class II |
| Regulation | 21 CFR 882.5897 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QBC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 28 |
| 2021 | 1 | 330 |
| 2022 | 1 | 119 |
| 2024 | 1 | 114 |
| 2025 | 2 | 100 |
| 2026 | 2 | 192 |
Compare with all 510(k) review times · Search every QBC clearance
Top QBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cala Health, Inc. | 6 | 2026-03-17 |
| Encora, Inc. | 1 | 2026-02-05 |
| Fasikl Incorporated | 1 | 2025-07-01 |
Most recent QBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253587 | Cala Health, Inc. | Cala kIQ Plus | 2026-03-17 | 120 |
| K251517 | Encora, Inc. | Encora X1 | 2026-02-05 | 265 |
| K250096 | Fasikl Incorporated | Felix NeuroAI System | 2025-07-01 | 168 |
| K243848 | Cala Health, Inc. | Cala kIQ | 2025-01-16 | 31 |
| K242259 | Cala Health, Inc. | Cala kIQ | 2024-11-22 | 114 |
Recalls for QBC devices
openFDA lists no recalls for product code QBC.
Frequently asked questions
What is FDA product code QBC?
QBC is the FDA product code for external upper limb tremor stimulator. It is a Class II device, regulated under 21 CFR 882.5897 and reviewed by the Neurology panel.
What device class is QBC?
Class II, regulation 21 CFR 882.5897. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBC?
Across 8 cleared submissions the average was 147 days from receipt to decision (median 120).
Which companies have the most QBC clearances?
Cala Health, Inc. (6); Encora, Inc. (1); Fasikl Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBC
- Run a recall and safety report across every QBC manufacturer
- Watch product code QBC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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