QBCClass II
External Upper Limb Tremor Stimulator
Neurology · 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.
MDR events6All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances9All time
Recent MDR events
6 adverse event reports on file
- CALA KIQApr 1, 2026InjuryCala Health Inc3011628389-2026-00001
- CALA KIQJun 18, 2025InjuryCala Health Inc3011628389-2025-00001
- CALA KIQDec 23, 2024InjuryCala Health3011628389-2024-00002
- CALA TRIOApr 11, 2023InjuryCala Health, Inc.MW5116561
- CALA TRIOMay 2, 2022InjuryCala Health, Inc.MW5109481
- CALA TRIOMar 1, 2021InjuryCala Health, Inc.MW5099703
Event type breakdown
Injury6
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Cala Health, Inc.Mar 17, 2026
K253587 · Cala kIQ Plus
- Encora, Inc.Feb 5, 2026
K251517 · Encora X1
- Fasikl IncorporatedJul 1, 2025
K250096 · Felix NeuroAI System
- Cala Health, Inc.Jan 16, 2025
K243848 · Cala kIQ
- Cala Health, Inc.Nov 22, 2024
K242259 · Cala kIQ
- Cala Health, Inc.Nov 22, 2022
K222237 · Cala kIQ
- Cala Health, Inc.Oct 5, 2021
K203288 · Cala Trio
- Cala Health, Inc.Oct 25, 2018
K182706 · External upper limb tremor stimulator