The following data is part of a De Novo classification by Cala Health, Inc. with the FDA for Cala One.
| DeNovo ID | DEN170028 |
| Device Name: | Cala ONE |
| Classification | External Upper Limb Tremor Stimulator |
| Applicant | Cala Health, Inc. 875 Mahler Road. suite 168 Burlingame, CA 94010 |
| Contact | Scott A. Wilson |
| Product Code | QBC |
| CFR Regulation Number | 882.5897 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2017-05-17 |
| Decision Date | 2018-04-26 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |