DEN170028 is an FDA 510(k) submission for the Cala ONE. 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 Not Cleared (DENG) decision on April 26, 2018.
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 | DEN170028 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 17, 2017 |
| Decision Date | April 26, 2018 |
| Days to Decision | 344 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | — |
| 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. |