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FDA PRODUCT CODE · CLASS II

QBC — External Upper Limb Tremor Stimulator

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5897
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K253587Cala Health, Inc. · 510k2026-03-17
K251517Encora, Inc. · 510k2026-02-05
K250096Fasikl Incorporated · 510k2025-07-01
K243848Cala Health, Inc. · 510k2025-01-16
K242259Cala Health, Inc. · 510k2024-11-22

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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