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# Class 2 for Upper Limb Tremor Stimulator
- URL: https://www.fdaweb.com/class-2-for-upper-limb-tremor-stimulator/
- Published: 2018-10-18T12:00:00.000Z
- Updated: 2026-09-15T00:39:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142617

*Federal Register* notice: FDA has classified the external upper limb tremor stimulator into Class 2 (special controls). The classification was in response to a Cala Health request for *de novo* classification of its Cala One. The classification has identified it as a prescription device that is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-17/pdf/2018-22695.pdf?ref=fdaweb.com).