FDA Product Code
FDA Product Code QBC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5897
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253587 | Cala kIQ Plus | Cala Health, Inc. | 2026-03-17 | Traditional | PDF ↗ |
| K251517 | Encora X1 | Encora, Inc. | 2026-02-05 | Traditional | PDF ↗ |
| K250096 | Felix NeuroAI System | Fasikl Incorporated | 2025-07-01 | Traditional | PDF ↗ |
| K243848 | Cala kIQ | Cala Health, Inc. | 2025-01-16 | Special | PDF ↗ |
| K242259 | Cala kIQ | Cala Health, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K222237 | Cala kIQ | Cala Health, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K203288 | Cala Trio | Cala Health, Inc. | 2021-10-05 | Traditional | PDF ↗ |
| K182706 | External upper limb tremor stimulator | Cala Health, Inc. | 2018-10-25 | Special | PDF ↗ |
| DEN170028 | Cala ONE | Cala Health, Inc. | 2018-04-26 | Direct | — |
Product code QBC · Class II · Neurology. Data: openFDA.