TELE-MADE DISPOSABLES, INC.

Tele-Made Disposables, Inc. specializes in two primary device categories: basic electric hospital beds and low-air-loss beds. These devices are designed for clinical use to support patient positioning and pressure redistribution in healthcare environments. Examples include models like the Patriot and TITAN.

The company is headquartered in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with FDA oversight for medical devices marketed in the US.

Tele-Made Disposables, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for compliance, traceability, and patient safety purposes.

The company’s devices fall under FDA Class II regulation. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.