External Upper Limb Tremor Stimulator
Regulation 882.5897
2510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QBC
| Company | 510(k)s | Recalls |
|---|---|---|
| Cala Health, Inc. | 7 | 0 |
| Encora, Inc. | 1 | 0 |
| Fasikl Incorporated | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2026 | K253587 | Cala kIQ Plus Cala Health, Inc. | QBC |
| Feb 5, 2026 | K251517 | Encora X1 Encora, Inc. | QBC |
| Jul 1, 2025 | K250096 | Felix NeuroAI System Fasikl Incorporated | QBC |
| Jan 16, 2025 | K243848 | Cala kIQ Cala Health, Inc. | QBC |
| Nov 22, 2024 | K242259 | Cala kIQ Cala Health, Inc. | QBC |
| Nov 22, 2022 | K222237 | Cala kIQ Cala Health, Inc. | QBC |
| Oct 5, 2021 | K203288 | Cala Trio Cala Health, Inc. | QBC |
| Oct 25, 2018 | K182706 | External upper limb tremor stimulator Cala Health, Inc. | QBC |
| Apr 26, 2018 | DEN170028 | Cala ONE Cala Health, Inc. | QBC |
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