Data / Medical devices / External Upper Limb Tremor Stimulator
External Upper Limb Tremor Stimulator (QBC): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make External Upper Limb Tremor Stimulator (product code QBC, Class 2, 21 CFR 882.5897). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on March 17, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QBC
- Device class
- 2
- Regulation
- 882.5897
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 1 |
Makers of External Upper Limb Tremor Stimulator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cala Health, Inc. | Foster City, CA, United States | Manufacturer | 5 | March 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Encora, Inc | Boston, MA, United States | Complaint file establishment, Specification developer | 1 | February 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fasikl Incorporated | Bloomington, MN, United States | Specification developer | 1 | July 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Fasikl Technology Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.