Skip to content

Disposable Pre-Gelled Surface Electrode

by Rochester Electro-Medical, Inc. 510(k)

Active United States

510(k) K142159

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142159 Date3 Jun 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GXY
FDA applicant
Rochester Electro Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Rochester Electro-Medical, Inc.