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ES 180-DCM Muscle Stimulator

by Promatek

510(k) K860619

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 NumberK860619 Date30 May 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  • Withdrawn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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
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 ES 180-DCM Muscle Stimulator is a Powered Muscle Stimulator (IPF), classified under FDA Product Code IPF. This device delivers controlled electrical currents to stimulate muscle contractions, aiding in physical therapy, rehabilitation, or pain management by targeting affected muscle groups through electrode contact.

This device is supplied as a reusable, electrically powered unit and is regulated under 21 CFR 890.5850 as a Class II medical device. Cleared via FDA 510(k) K860619 under the Physical Medicine advisory committee in 1986, it operates within standard clinical settings. No sterility or single-use requirements are specified, and its MRI safety is not documented in the available data.

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 ES 180-DCM Muscle Stimulator used for?

    The ES 180-DCM Muscle Stimulator is designed to deliver controlled electrical currents to stimulate muscle contractions. This aids in physical therapy, rehabilitation, and pain management by targeting affected muscle groups through electrode contact, helping restore function or alleviate discomfort.

  • Is the ES 180-DCM Muscle Stimulator reusable or single-use?

    The ES 180-DCM Muscle Stimulator is supplied as a reusable device. It is intended for repeated use in clinical settings, provided it is maintained according to manufacturer guidelines and regulatory standards.

  • Does the ES 180-DCM Muscle Stimulator require sterilization?

    No sterility requirements are specified for the ES 180-DCM Muscle Stimulator. Since it is a reusable, electrically powered unit, standard cleaning and maintenance procedures should be followed to ensure safe and effective use.

  • What regulatory pathway does the ES 180-DCM Muscle Stimulator follow?

    The ES 180-DCM Muscle Stimulator is classified as a Class II medical device under FDA Product Code IPF and was cleared via an FDA 510(k) submission (K860619) in 1986. It is regulated under 21 CFR 890.5850 and was determined to be substantially equivalent through the Physical Medicine advisory committee.

  • Can the ES 180-DCM Muscle Stimulator be used in MRI environments?

    The available data does not document MRI safety for the ES 180-DCM Muscle Stimulator. Clinicians should verify compatibility with their specific MRI equipment and protocols before use in an MRI environment to avoid potential risks.