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Telesis® 9250-St

by Prometheus Group of New Hampshire Limited, the

Telesis® 9250-St is a Class II device made by Prometheus Group of New Hampshire Limited, the, listed in FDA GUDID since 3 Oct 2019 (UDI-DI 00852423006431), 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 Number00852423006431 UDI-DI Date3 Oct 2019ListedStatusListed 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  • Withdrawn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
Telesis®
Generic name
Biofeedback system application software
Model / Ref / Catalog
9250-ST
Primary DI / UDI-DI
00852423006431
FDA product code
HCC
GMDN term
Biofeedback system application software
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Prometheus Group of New Hampshire Limited, the

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Properties

  • Prescription use
  • Premarket exempt
Other properties (13, all answered No)