FDA 510(k) Device Information

FDA-Cleared Medical Devices

HealthWright Technologies is an authorized distributor of FDA-cleared medical devices for healthcare practices. All devices we distribute have received 510(k) premarket clearance from the U.S. Food and Drug Administration, confirming they are substantially equivalent to legally marketed predicate devices.

What is FDA 510(k) Clearance?

A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is at least as safe and effective as a legally marketed device that is not subject to premarket approval. FDA 510(k) clearance allows a device to be commercially distributed in the United States. You can verify the 510(k) clearance status of any medical device through the FDA 510(k) Premarket Notification Database.

Our Product Lines

Hako-Med Horizontal Therapy Systems

The Hako-Med Horizontal Therapy system is an FDA-cleared electrotherapy device used for pain management and rehabilitation. It delivers proprietary bioelectrical signals for the treatment of chronic and acute pain conditions. The device is indicated for use by licensed healthcare professionals in clinical settings. Please refer to the manufacturer’s product labeling for complete indications, contraindications, and 510(k) clearance details.

TM-Flow System

The TM-Flow is an FDA-cleared diagnostic testing system that provides non-invasive assessments including autonomic nervous system testing, ankle-brachial index (ABI) measurements, and sudomotor function testing. These tests support early detection of peripheral neuropathy, peripheral arterial disease, and cardiac autonomic neuropathy. The device is intended for use by healthcare professionals as part of a comprehensive patient evaluation.

SCRIPT Physician Dispensing Solutions

The SCRIPT system provides physician point-of-care dispensing solutions, enabling healthcare providers to dispense FDA-approved medications directly to patients at the time of their visit. All medications dispensed through the SCRIPT system are FDA-approved pharmaceutical products. Dispensing is subject to applicable state pharmacy regulations and licensing requirements.

CMAT Advantage™ System

The CMAT Advantage system is a cloud-based practice management and billing solution designed specifically for medical practices utilizing the devices and services distributed by HealthWright Technologies. As a software platform, it supports clinical workflow management and billing processes.

Verification and Documentation

Healthcare providers may request copies of 510(k) clearance letters, product labeling, and manufacturer documentation for any device distributed by HealthWright Technologies. Please contact us at contact@healthwrighttechnologies.com for regulatory documentation requests.

Disclaimer: The information on this page is provided for general informational purposes and does not constitute medical advice. Product-specific regulatory information, indications for use, contraindications, warnings, and precautions are available in each product’s Instructions for Use and labeling. Healthcare providers should always refer to complete product labeling before using any medical device. Last updated: April 2026.

Understanding the FDA 510(k) Clearance Process

The FDA 510(k) premarket notification is a regulatory pathway that allows medical device manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This process is critical for ensuring that medical devices meet rigorous safety and effectiveness standards before reaching healthcare providers and patients.

HealthWright Technologies exclusively distributes devices that have successfully completed the 510(k) clearance process. Each device in our catalog has been thoroughly reviewed by the FDA, confirming that it performs as intended and meets all applicable safety requirements. Our commitment to distributing only FDA-cleared devices reflects our dedication to patient safety and clinical excellence.

Why FDA Clearance Matters for Your Practice

When you choose FDA-cleared medical devices from HealthWright Technologies, you can be confident that each product has undergone thorough evaluation. FDA clearance provides assurance of device safety, manufacturing quality, and accurate labeling. For healthcare providers, using FDA-cleared devices also supports proper insurance reimbursement and compliance with facility accreditation requirements.

If you have questions about the FDA clearance status of any device in our catalog, please contact us at contact@healthwrighttechnologies.com. Our team can provide detailed regulatory documentation, including 510(k) summary letters and device classification information.