Skip to content

Biofeedback Bio 80

by Bimed, Inc.

510(k) K803099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK803099 Date2 Mar 1981ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Biofeedback Bio 80 is a biofeedback device used for neurological applications. It is designed to provide biofeedback information to users or healthcare professionals.

The device is supplied by Bimed, Inc. and has FDA 510(k) clearance with the K803099 number. It is classified under product code HCC and is intended for use in neurology settings.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Biofeedback Bio 80 device used for?

    The Biofeedback Bio 80 is a biofeedback device specifically designed for neurological applications. It provides biofeedback information to users or healthcare professionals in neurology settings to assist in monitoring and training physiological functions.

  • How is the Biofeedback Bio 80 supplied and what is its regulatory status?

    The device is supplied by Bimed, Inc. and has FDA 510(k) clearance with the K803099 number. It is classified under product code HCC and is intended for use in neurology settings. The device is substantially equivalent to other devices in this category.

  • Is the Biofeedback Bio 80 a single-use device or can it be reused?

    The device data does not specify whether the Biofeedback Bio 80 is single-use or reusable. For information on sterilization and reuse protocols, please consult the manufacturer's instructions or contact Bimed, Inc. directly.

  • What are the storage requirements for the Biofeedback Bio 80?

    The device data does not provide specific storage requirements for the Biofeedback Bio 80. Proper storage conditions should be determined based on the manufacturer's guidelines to maintain device functionality and safety.