Infra-Link
by Zygo Industries, Inc. 510(k)
Active
510(k) K926029
Overview
The Infra-Link is a System, Environmental Control, Powered, designed for physical medicine applications. It functions as a controlled environmental device, likely intended for therapeutic or diagnostic procedures requiring precise temperature, humidity, or airflow regulation.
This device is supplied as a reusable system, with regulatory clearance under FDA 510(k) K926029 and classified as a Class II medical device under 21 CFR 890.3725. It is intended for use in clinical settings where environmental control is critical, though no specific sterility or MRI safety information is provided in the data. The product code IQA identifies its submission category within the FDA’s regulatory framework.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926029 | Date26 Mar 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3725
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zygo Industries, Inc.
Questions
Is the Infra-Link designed for single-use or can it be reused in clinical settings?
The Infra-Link is explicitly described as a reusable system, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. Since no sterility requirements are mentioned, its reuse is contingent on adherence to facility protocols for decontamination and environmental control.
What types of clinical procedures or specialties would benefit most from using the Infra-Link?
The Infra-Link is classified under Physical Medicine in the FDA’s regulatory framework, suggesting it is primarily used in settings where controlled environmental conditions—such as precise temperature, humidity, or airflow—are critical. This includes therapeutic or diagnostic applications like wound care, hydrotherapy, or rehabilitation where environmental regulation enhances treatment efficacy.
How is the Infra-Link supplied, and are there multiple models or configurations available?
The Infra-Link is supplied as a reusable system, though the exact configurations or models are not detailed in the provided data. The FDA’s product code (IQA) and multiple registration numbers (e.g., 3006789226, 3012505893) imply there may be variations or upgrades, but no specific sizes, accessories, or model distinctions are listed. Contacting Zygo Industries directly would provide clarity on available options.
What storage or maintenance requirements should be followed for the Infra-Link?
Since the Infra-Link is reusable, proper storage involves protecting it from environmental contaminants and ensuring it remains operational for repeated use. While no specific storage conditions (e.g., temperature, humidity) are mentioned, standard practices for reusable medical devices—such as cleaning, drying, and storing in a clean, dry environment—should be followed. Always refer to Zygo Industries’ operational manual for device-specific guidelines.
How was the Infra-Link’s regulatory pathway determined, and what does the FDA’s classification mean for its use?
The Infra-Link received FDA 510(k) clearance (K926029) under the Traditional pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. Its classification as a Class II medical device (21 CFR 890.3725) indicates it poses moderate risk and requires compliance with special controls, but it does not require pre-market approval. Clinically, this means it is subject to quality system regulations but does not carry the same stringent scrutiny as Class III devices.