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Pathway CTS2000

by Prometheus Group of New Hampshire Limited, the

Pathway CTS2000 is a psychophysiological biofeedback system (FDA Class II; FDA product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence) made by Prometheus Group of New Hampshire Limited, the, listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00852423006011), 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 Number00852423006011 UDI-DI Date26 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  • Withdrawn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
Pathway
Generic name
Psychophysiological biofeedback system
Model / Ref / Catalog
CTS2000
Primary DI / UDI-DI
00852423006011
FDA product code
KPI
GMDN term
Psychophysiological biofeedback system
Device class
Class II
Regulation number
876.5320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Psychophysiological biofeedback systemPerineal orifice incontinence-control electrical stimulation system, professional

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Other devices from Prometheus Group of New Hampshire Limited, the

See all devices from Prometheus Group of New Hampshire Limited, the →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)