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NeuroEDUCATOR PL-21-1000

by Control Bionics Incorporated

NeuroEDUCATOR PL-21-1000 is a Class II device made by Control Bionics Incorporated, cleared under FDA 510(k) K854277 on 21 Jan 1986 and listed in FDA GUDID since 6 Mar 2018 (UDI-DI 00864267000421), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K854277

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864267000421 UDI-DI Date6 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK854277 Date21 Jan 1986DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K854277 decided 21 Jan 1986 Active
  • FDA GUDID UDI-DI 00864267000421 listed 6 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K854277
  2. Listed FDA GUDID 00864267000421

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeuroEDUCATOR
Generic name
Biofeedback system
Model / reference
PL-21-1000
Primary DI / UDI-DI
00864267000421
510(k) Number
FDA product code
HCC
GMDN term
Biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Biofeedback system

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

Other devices from Control Bionics Incorporated

Properties

  • Serial number
Other properties (14, all answered No)