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Ami E-Z-Pace Electode

by A.M.I. Corp. 510(k)

Active United States

510(k) K854924

Overview

The Ami E-Z-Pace Electode is a Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) device. It is classified as a class 2 device. The device is used in the cardiovascular medical specialty.

The device is supplied by A.M.I. Corp. and has a product code of DRO. It has been assigned the regulation number 870.5550 and has the k number K854924. The device was cleared on February 26, 1986, with a decision code of SESE, indicating that it is substantially equivalent to a predicate device.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854924 Date26 Feb 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DRO
Device Class
Class II
Regulation
21 CFR Part 870.5550
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent