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Em Electrode

by Electromed Intl., Ltd.

510(k) K853774

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK853774 Date17 Apr 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Em Electrode is a medical device used in the cardiovascular field. It is classified as a class 2 device under the FDA regulation number 870.2360. The device is substantially equivalent to other devices on the market.

The Em Electrode is supplied with a product code of DRX and has been cleared by the FDA with a traditional clearance type. It was reviewed by the Cardiovascular advisory committee and received FDA 510K authorization. The device was decisioned as substantially equivalent on April 17, 1986.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Em Electrode used for?

    The Em Electrode is used in the cardiovascular field, specifically as a class 2 medical device under FDA regulation number 870.2360.

  • How is the Em Electrode supplied?

    The Em Electrode is supplied with a product code of DRX, indicating its classification and regulatory status.

  • Is the Em Electrode substantially equivalent to other devices?

    Yes, the Em Electrode was decisioned as substantially equivalent to other devices on the market on April 17, 1986, by the FDA.