Electronic Control Unit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K761087 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Aquamatic K-77

  Class II

  FDA 510(k) K770839 Active Cleared 8 Jun 1977

• Aquamatic K-Module Model K-10

  Class I

  FDA 510(k) K761337 Active Cleared 10 Jan 1977

• Aquamatic K-Module Model K-20

  Class II

  FDA 510(k) K771537 Active Cleared 6 Sep 1977

• Blood/Fluid Warmer Model Dw-1000A

  Class II

  FDA 510(k) K770232 Active Cleared 14 Feb 1977

• Disposable K-Pads

  Class II

  FDA 510(k) K760910 Active Cleared 16 Dec 1976

• What is the Gorman Rupp Electronic Control Unit used for?

  The Electronic Control Unit is designed as the operational interface for thermal regulation systems. It manages critical parameters like temperature, flow, and operational sequences to maintain precise environmental or process control. This makes it ideal for applications in industrial heating, cooling, or wastewater treatment where automated monitoring and adjustments are essential.

• How is the Electronic Control Unit supplied and where can it be used?

  The unit is supplied as a standalone device, meaning it is not part of a kit or bundled with other components. It is intended for use in controlled environments such as industrial facilities, wastewater treatment plants, or similar settings where thermal regulation is critical. Its standalone nature allows for flexible integration with compatible thermal regulation systems as specified by the manufacturer.

• Is the Electronic Control Unit single-use or reusable?

  The provided data does not classify the Electronic Control Unit as single-use or reusable. Since it is designed for integration into thermal regulation systems and operates in controlled environments, its longevity and maintenance depend on the manufacturer’s guidelines and the specific application requirements. It is not intended for sterilization, as it is not a medical device requiring such procedures.

• What regulatory status does the Electronic Control Unit hold?

  The Electronic Control Unit holds FDA 510(k) clearance under the classification of Thermal Regulating Systems (regulation number 870.5900). It was granted clearance in 1976 under the K-number K761087 and is classified as substantially equivalent under the decision code SESE. This clearance indicates that the device meets FDA requirements for safety and effectiveness as a thermal regulating system.

• Can the Electronic Control Unit be integrated with other systems?

  Yes, the Electronic Control Unit is specifically designed for integration with compatible thermal regulation systems. While the exact specifications for compatibility are not detailed in the provided data, the manufacturer’s documentation would outline which systems it can pair with. This modular design ensures flexibility for applications requiring precise thermal control in industrial or wastewater treatment environments.