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

FDA 510(k)

VIVATRAK

K-Number: K101109 · 2010-07-15

ApplicantWireless Medcare, LLC
Decision Date2010-07-15
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VIVATRAK is the device name listed in this FDA 510(k) record. The listed applicant is Wireless Medcare, LLC. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K101109. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVATRAK?

VIVATRAK is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Wireless Medcare, LLC. The 510(k) number is K101109.

When did VIVATRAK receive FDA 510(k) clearance?

VIVATRAK received FDA 510(k) clearance on 2010-07-15, under 510(k) number K101109.

Who is the listed applicant for VIVATRAK?

The FDA 510(k) record lists Wireless Medcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVATRAK?

The FDA product code for VIVATRAK is KMI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: KMI)

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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLCK130752DYNASENSE SYSTEMCentauri Medical, Inc.K090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.K933552PM-PAGERHill Engineering

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.

↑