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Ondamed 001-57-0101

by Ondamed Inc.

Ondamed 001-57-0101 is a Class II device made by Ondamed Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00852318007574), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852318007574 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ondamed
Generic name
Biofeedback system
Model / Ref / Catalog
001-57-0101
Primary DI / UDI-DI
00852318007574
FDA product code
HCC
GMDN term
Biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Biofeedback system

Similar devices

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

Other devices from Ondamed Inc.

See all devices from Ondamed Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)