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HotDog Warming Mattress + Return Electrode

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210727

by Augustine Temperature Management, LLC

Identifiers

510(k) Number
K210727 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HotDog Warming Mattress + Return Electrode is a reusable surgical mattress overlay designed for patient warming and electrosurgical grounding. It combines underbody warming with a return electrode to provide simultaneous thermal management and safe electrical grounding during surgical procedures.

This device is intended for use in operating rooms and surgical settings, where it is placed under the patient to deliver controlled warming while maintaining electrosurgical safety. Supplied as a reusable component, it requires connection to an electrosurgical generator and a WC77 Temperature Management Controller for operation. The device holds an FDA 510(k) clearance under product code GEI, with a classification as substantially equivalent to a predicate device.

Frequently asked questions

What is the HotDog Warming Mattress + Return Electrode primarily used for in surgical settings?

The HotDog Warming Mattress + Return Electrode is designed to provide simultaneous patient warming and safe electrosurgical grounding during surgical procedures. It acts as a reusable surgical mattress overlay placed under the patient, delivering controlled underbody warmth while ensuring proper electrical grounding when connected to an electrosurgical generator and the WC77 Temperature Management Controller.

Is this device single-use or reusable, and how does that affect its use in the operating room?

The HotDog Warming Mattress + Return Electrode is reusable, which means it can be cleaned and reused across multiple surgical procedures. This design reduces waste and costs while maintaining functionality for consistent patient warming and grounding safety in the operating room.

What external equipment is required to operate the HotDog Warming Mattress + Return Electrode?

To operate the HotDog Warming Mattress + Return Electrode, it must be connected to two external devices: an electrosurgical generator (for grounding) and the WC77 Temperature Management Controller (for controlling the warming function). These connections ensure both thermal management and electrical safety during use.

How is the device classified by the FDA, and what does that mean for its regulatory status?

The HotDog Warming Mattress + Return Electrode holds an FDA 510(k) clearance under product code GEI, with a classification as substantially equivalent (SESE) to a predicate device. This means it has been determined to have the same intended use and technological characteristics as a legally marketed device, allowing it to be marketed in the U.S. without further approval beyond the clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Patient Warming Mattress + Return Electrode - HotDog Patient Warming, HotDog Patient Warming System | Air-Free Warming & Grounding, HotDog Warming Mattress + Return Electrode (K232627) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Augustine Temperature Management, LLC

Sources (1)

  • FDA 510(k) K210727 24 fields · synced Sep 19, 2026