Disposable Needle Electrode

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K961013 ↗

FDA Product Code

IKT

Device Class

Class II

Regulation

21 CFR Part 890.1385

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K922548 Active Cleared 3 Nov 1992

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  FDA 510(k) K912775 Active Cleared 8 Nov 1991

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  Class I

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  FDA 510(k) K920127 Active Cleared 10 Jun 1992

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  Class II

  FDA 510(k) K865106 Active Cleared 20 May 1987

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  Class II

  FDA 510(k) K854622 Active Cleared 11 Apr 1986

See all devices from Medelec Intl. Corp. →