K251517 is an FDA 510(k) clearance for the Encora X1. This device is classified as a External Upper Limb Tremor Stimulator (Class II - Special Controls, product code QBC).
Submitted by Encora, Inc. (Boston, US). The FDA issued a Cleared decision on February 5, 2026, 265 days after receiving the submission on May 16, 2025.
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 | K251517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2025 |
| Decision Date | February 05, 2026 |
| Days to Decision | 265 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. |