Feedback EDR System Model EDR-100

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

510(k) Number

K770790 ↗

FDA Product Code

HCC

Device Class

Class II

Regulation

21 CFR Part 882.5050

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Isolated Voltage/Frequency Converter

  Class II

  FDA 510(k) K812619 Active Cleared 8 Oct 1981

• Temperature Feedback Sys, Model DT100

  Class II

  FDA 510(k) K770270 Active Cleared 24 Feb 1977

• Isolated Solid-State Relay Multiplexer & F/F Conv

  Class II

  FDA 510(k) K860914 Active Cleared 6 Jun 1986

• Feedback EMG System, Model Pe-L00

  Class II

  FDA 510(k) K770663 Active Cleared 26 Apr 1977

• Feedback EMG System Pe-020

  Class II

  FDA 510(k) K832333 Active Cleared 1 Sep 1983

• Miniature Temperature Trainer Model Dt-002

  Class II

  FDA 510(k) K905373 Active Cleared 10 Apr 1991

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• What is the Feedback EDR System Model EDR-100 used for?

  The Feedback EDR System Model EDR-100 is a biofeedback device designed to measure electrodermal response, providing feedback on physiological responses. It is intended for biofeedback purposes to help monitor and understand certain bodily reactions.

• How is the Feedback EDR System Model EDR-100 supplied?

  The device is supplied with various model numbers and registration numbers as specified in the authorization data. It is manufactured by Bio-Feedback Systems, Inc. and comes with the necessary components for measuring electrodermal response.

• What is the regulatory status of the Feedback EDR System Model EDR-100?

  The Feedback EDR System Model EDR-100 received FDA 510(k) clearance on May 10, 1977. It is classified as a Class II device with product code HCC and is regulated under 882.5050.

• Is the Feedback EDR System Model EDR-100 reusable or single-use?

  The device data does not specify whether the Feedback EDR System Model EDR-100 is designed for single-use or multiple uses. For specific usage instructions, please refer to the manufacturer's documentation or contact Bio-Feedback Systems, Inc. directly.