Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

External upper limb tremor stimulator

K-Number: K182706 · 2018-10-25

ApplicantCala Health, Inc.
Decision Date2018-10-25
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

External upper limb tremor stimulator is a medical device manufactured by Cala Health, Inc.. It received FDA 510(k) clearance on 2018-10-25 under approval number K182706. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the External upper limb tremor stimulator?

External upper limb tremor stimulator is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Cala Health, Inc.. The 510(k) number is K182706.

When was External upper limb tremor stimulator approved by the FDA?

External upper limb tremor stimulator received FDA 510(k) clearance on 2018-10-25, under approval number K182706.

What company makes External upper limb tremor stimulator?

External upper limb tremor stimulator is manufactured by Cala Health, Inc..

What is the FDA product code for External upper limb tremor stimulator?

The FDA product code for External upper limb tremor stimulator is QBC.

Related Clinical Trials

NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT01581580 Deep Brain Stimulation Surgery for Movement Disorders RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT05897775 Coordinated Reset Deep Brain Stimulation for Essential Tremor RECRUITING NCT06303869 Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke RECRUITING NCT07574268 Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial COMPLETED

Other Devices by Cala Health, Inc.

DEN170028Cala ONE K203288Cala Trio K222237Cala kIQ K242259Cala kIQ K243848Cala kIQ K253587Cala kIQ Plus

View all 7 devices →

Related Devices (Code: QBC)

DEN170028Cala ONECala Health, Inc. K203288Cala TrioCala Health, Inc. K222237Cala kIQCala Health, Inc. K242259Cala kIQCala Health, Inc. K250096Felix NeuroAI SystemFasikl Incorporated K243848Cala kIQCala Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑