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)

Stimulation System (PA series, PR series, S series and Q series)

K-Number: K232786 · 2024-05-16

ApplicantEdan Instruments, Inc.
Decision Date2024-05-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Stimulation System (PA series, PR series, S series and Q series) is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2024-05-16 under approval number K232786. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stimulation System (PA series, PR series, S series and Q series)?

Stimulation System (PA series, PR series, S series and Q series) is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K232786.

When was Stimulation System (PA series, PR series, S series and Q series) approved by the FDA?

Stimulation System (PA series, PR series, S series and Q series) received FDA 510(k) clearance on 2024-05-16, under approval number K232786.

What company makes Stimulation System (PA series, PR series, S series and Q series)?

Stimulation System (PA series, PR series, S series and Q series) is manufactured by Edan Instruments, Inc..

What is the FDA product code for Stimulation System (PA series, PR series, S series and Q series)?

The FDA product code for Stimulation System (PA series, PR series, S series and Q series) is IPF.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT07267910 Measuring Vestibular Organ Function With Weak Alternating Current Stimulation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021)

Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

View all 48 devices →

Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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.

↑