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ALGO Pro 036235

by Xltek

ALGO Pro 036235 is a Class II device made by Xltek, listed in FDA GUDID since 26 Mar 2024 (UDI-DI 00382830062015), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00382830062015 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: not 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  • Withdrawn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
ALGO Pro
Generic name
Auditory stimulator
Model / reference
036235
Primary DI / UDI-DI
00382830062015
FDA product code
GWJ
GMDN term
Auditory stimulator
Device class
Class II
Regulation number
882.1900
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Auditory stimulator

Similar devices in this category

Other devices filed under Auditory stimulator.

Other devices from Xltek

See all devices from Xltek →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)