Product Safety Information

HealthWright Technologies is committed to the safety and well-being of patients and healthcare providers who use the medical devices and diagnostic equipment we distribute. This page provides safety information, reporting guidelines, and resources to help support the safe and effective use of the products available through our catalog.

Our Commitment to Patient Safety

Patient safety is central to our business. We distribute medical devices that are made by their manufacturers, and healthcare providers should rely on each manufacturer’s labeling and their own clinical judgment when selecting and using a device.

For the CMAT diagnostic systems we install, each unit is identified by its serial number and shipment tracking number, which lets us reach the practices that received a specific unit if a manufacturer or the FDA issues a recall or safety notice affecting it. When a CMAT issue is reported to us, we open a support ticket for it, and we escalate any report of patient harm or risk to management and to LD Technology the same day.

Safe Use Guidelines

All medical devices should be used in accordance with their labeling, Instructions for Use (IFU), and the clinical judgment of qualified healthcare professionals. Before using any device, practitioners should thoroughly review the manufacturer’s documentation, including intended-use statements, contraindications, warnings, precautions, and adverse-event information. Devices should only be used for their FDA-cleared indications and by personnel who have received appropriate training on the specific device.

Proper device maintenance and calibration are critical to continued safety and performance. Follow the manufacturer’s recommended maintenance schedules, cleaning procedures, and calibration protocols. Do not use devices that appear damaged, have expired components, or are not functioning according to specifications. Single-use devices and consumable components such as electrodes and mouth pieces should never be reused or reprocessed, as doing so may compromise sterility, device performance, and patient safety.

Reporting Safety Concerns

If you experience or become aware of any adverse event, device malfunction, or safety concern related to a product purchased from HealthWright Technologies, we encourage you to report it promptly. Email us at contact@healthwrighttechnologies.com or call (678) 322-7146 and we will follow up. Please include the product name, model or serial number, a description of the event, and whether any patient injury occurred. We will review your report and follow up with you.

Healthcare providers, patients, and consumers can also report adverse events and product problems directly to the FDA through MedWatch, the FDA’s medical product safety reporting program. Reports can be submitted online using the FDA’s MedWatch reporting form at accessdata.fda.gov/scripts/medwatch. Reporting problems helps the FDA monitor the safety of medical products.

Product Recalls and Safety Alerts

If a manufacturer or the FDA issues a recall or safety alert for a product we supplied, and we are able to identify the customers who received it, we will pass along the manufacturer’s and the FDA’s instructions for returning, disposing of, or continuing to use the affected product. If you believe you have received a recalled product, please contact us for guidance.

Healthcare providers can also independently monitor the FDA’s recall database and subscribe to the FDA’s MedWatch safety alerts to stay informed about issues that may affect devices in their practice.

Medical Disclaimer

The information provided on this page and throughout the HealthWright Technologies website is intended for healthcare professionals and is not a substitute for professional medical judgment. Product descriptions, clinical applications, and safety information are provided for informational purposes and should be considered alongside the complete manufacturer labeling, clinical evidence, and the specific needs of individual patients. Healthcare providers should exercise independent clinical judgment in all treatment decisions and device selections. For complete product safety data, always refer to the manufacturer’s official Instructions for Use and labeling documentation. For additional information about our compliance standards, visit our Regulatory Compliance page, or review our FDA 510(k) Device Information page for details about the clearance status of specific products.

Medical Device Safety Standards

The TM-Flow diagnostic system, our primary medical device offering, is built on FDA-cleared component devices manufactured by LD Technology, including the TBL-ABI System cleared under 510(k) K173696. There is no single integrated system clearance. A 510(k) clearance confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.