K243848 is an FDA 510(k) clearance for the Cala kIQ. This device is classified as a External Upper Limb Tremor Stimulator (Class II - Special Controls, product code QBC).
Submitted by Cala Health, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 16, 2025, 31 days after receiving the submission on December 16, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5897. 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..
| 510(k) Number | K243848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QBC — External Upper Limb Tremor Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5897 |
| 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. |