K203288 is an FDA 510(k) clearance for the Cala Trio. This device is classified as a External Upper Limb Tremor Stimulator (Class II - Special Controls, product code QBC).
Submitted by Cala Health, Inc. (Burlingame, US). The FDA issued a Cleared decision on October 5, 2021, 330 days after receiving the submission on November 9, 2020.
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 | K203288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2020 |
| Decision Date | October 05, 2021 |
| Days to Decision | 330 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. |