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Kit, Hybresis Controller 199587-001

by Empi

Kit, Hybresis Controller 199587-001 is a Class II device made by Empi, listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00888912151252), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888912151252 UDI-DI Date24 Sep 2014ListedStatusListed 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  • Withdrawn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
Kit, Hybresis Controller
Generic name
Drug-delivery iontophoresis system, reusable
Model / reference
199587-001
Primary DI / UDI-DI
00888912151252
FDA product code
EGJ
GMDN term
Drug-delivery iontophoresis system, reusable
Device class
Class II
Regulation number
890.5525
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code EGJ (Device, Iontophoresis, Other Uses).

Other devices from Empi

See all devices from Empi →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)