K222237 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 November 22, 2022, 119 days after receiving the submission on July 26, 2022.
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 | K222237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2022 |
| Decision Date | November 22, 2022 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| 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. |