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Neuroband GFM30MD

by Dreem GUDID

Withdrawn United States

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850010086026 UDI-DIDate20 Sep 2021ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Neuroband
Generic Name
Psychophysiological biofeedback system
Model / Reference
GFM30MD
Primary DI / UDI-DI
00850010086026
FDA Product Code
HCC
GMDN Term
Psychophysiological biofeedback system
Device Class
Class II
Regulation Number
882.5050
Commercial Distribution
Not in Commercial Distribution

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No