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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 the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) 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. The listed applicant is Cala Health, Inc.. The 510(k) number is K182706.

When did External upper limb tremor stimulator receive FDA 510(k) clearance?

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

Who is the listed applicant for External upper limb tremor stimulator?

The FDA 510(k) record lists Cala Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05842434Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's TremorCOMPLETEDNCT06235190Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential TremorCOMPLETEDNCT06303869Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical StrokeRECRUITINGNCT06951035Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic StrokeRECRUITINGNCT07501429Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord InjuryRECRUITINGNCT07631390Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic QuadriplegiaCOMPLETED

Other records listing Cala Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253587Cala kIQ PlusK243848Cala kIQK242259Cala kIQK222237Cala kIQK203288Cala Trio

Related Devices (Code: QBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253587Cala kIQ PlusCala Health, Inc.K251517Encora X1Encora, Inc.K250096Felix NeuroAI SystemFasikl IncorporatedK243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K222237Cala kIQCala Health, Inc.

Official Source

View on FDA Database →

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