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FDA 510(k)

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

K-Number: K181070 · 2019-02-01

ApplicantAndon Health Co, Ltd.
Decision Date2019-02-01
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2019-02-01 under approval number K181070. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)?

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K181070.

When was iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) approved by the FDA?

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) received FDA 510(k) clearance on 2019-02-01, under approval number K181070.

What company makes iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)?

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is manufactured by Andon Health Co, Ltd..

What is the FDA product code for iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)?

The FDA product code for iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is NBW. This falls under the OB/GYN category.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 40884106 Biosensor-embedded wearables for dry eye monitoring and management. Expert review of medical devices (2025) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Andon Health Co, Ltd.

K153286iHealth Align Gluco-Monitoring system K153278Wireless Smart Gluco-Monitoring System K160565Fully Automatic Electronic Blood Pressure Monitor K160563Fully Automatic Electronic Blood Pressure Monitor K160014iHealth Track Blood Pressure Monitor K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

View all 31 devices →

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

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.

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