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Ez-Stik Electrodes

by Naimco, Inc.

510(k) K050469

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050469 Date13 May 2005ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0815-2013 FDA Class II initiated 30 Nov 2009
    • Terminated Z-0816-2013 FDA Class II initiated 30 Nov 2009
    • Terminated Z-0818-2013 FDA Class II initiated 30 Nov 2009
    • Terminated Z-0817-2013 FDA Class II initiated 30 Nov 2009

    Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXY
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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