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StimRouter ST2-SW01

by Bioness Inc.

StimRouter ST2-SW01 is a Class II device made by Bioness Inc., listed in FDA GUDID since 8 Feb 2018 (UDI-DI 00815962020306), 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 Number00815962020306 UDI-DI Date8 Feb 2018ListedStatusListed 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  • Withdrawn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
StimRouter
Generic name
Transcutaneous electrical stimulation probe
Model / reference
ST2-SW01
Description
Clinician Programmer Software
Primary DI / UDI-DI
00815962020306
FDA product code
GZF
GMDN term
Transcutaneous electrical stimulation probe
Device class
Class II
Regulation number
882.5870
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code GZF (STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)).

Other devices from Bioness Inc.

See all devices from Bioness Inc. →

Properties

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