510(k) K250096
- Device
- Felix NeuroAI System
- Applicant
- Fasikl Incorporated
- 510(k) number
- K250096
- Product code
- QBC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-01
- Date received
- 2025-01-14
- Regulation
- 882.5897
- Classification name
- External Upper Limb Tremor Stimulator
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zhen Zhang
- Address
- 8500 Normandale Lake Blvd., Suite 400 Bloomington MN US 55437 55437
FDA Registration Numbers#
- 3038912617
- 3031696786
- 3043526479
- 3011628389
Source Documents#
Other 510(k) Records For Product Code QBC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253587 | Cala kIQ Plus | Cala Health, Inc. | 2026-03-17 |
| K251517 | Encora X1 | Encora, Inc. | 2026-02-05 |
| K243848 | Cala kIQ | Cala Health, Inc. | 2025-01-16 |
| K242259 | Cala kIQ | Cala Health, Inc. | 2024-11-22 |
| K222237 | Cala kIQ | Cala Health, Inc. | 2022-11-22 |
| K203288 | Cala Trio | Cala Health, Inc. | 2021-10-05 |
| K182706 | External upper limb tremor stimulator | Cala Health, Inc. | 2018-10-25 |
| DEN170028 | Cala ONE | Cala Health, Inc. | 2018-04-26 |