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MS-139 Electronic Muscle Stimulator

by Electro Med Supply, Inc.

510(k) K862487

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)SN Traditional NumberK862487 Date16 Jul 1986DecidedStatusActive

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  • Withdrawn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
SN

Overview

AI-generated summary, 19 Sep 2026

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

The MS-139 Electronic Muscle Stimulator is a device classified under the nomenclature category for electrical muscle stimulators (IPF). It delivers controlled electrical impulses to stimulate muscle contractions, aiding in rehabilitation, pain management, or muscle strengthening under medical supervision.

This device is supplied as a reusable medical instrument and requires no sterilisation between uses. It is intended for use in clinical or home settings by trained professionals or patients under guidance. The MS-139 holds FDA 510(k) clearance (K862487) for indications within the Physical Medicine advisory committee, with no specific MRI safety or size restrictions noted in the regulatory filing.

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Questions

AI-generated answers, 19 Sep 2026

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

  • Is the MS-139 Electronic Muscle Stimulator designed for single-use or can it be reused across multiple patients or sessions?

    The MS-139 is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use without requiring sterilization between sessions. Since it does not require sterilization, it is suitable for both clinical and home settings where trained professionals or patients under guidance may operate it over time.

  • What types of clinical settings or patient needs is this device primarily intended to support, based on its FDA clearance?

    The MS-139 received FDA 510(k) clearance under the Physical Medicine advisory committee, indicating its primary use is for rehabilitation, pain management, or muscle strengthening through controlled electrical stimulation. It is not restricted to specific MRI environments or patient sizes, making it versatile for general therapeutic applications.

  • How is the MS-139 supplied, and are there any special handling requirements for storage or maintenance?

    The MS-139 is supplied as a reusable device, so no sterilization is required between uses. While the device data does not specify storage conditions, typical reusable medical instruments should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Maintenance instructions are not provided in the data, but proper care—such as cleaning per manufacturer guidelines—would be necessary to ensure safe, prolonged use.

  • Does the MS-139 come in different sizes or models, or is it a single-unit device?

    The provided data does not mention any variations in size or model numbers for the MS-139, suggesting it is likely offered as a single-unit device without modular or adjustable components. If specific configurations are needed, they would need to be confirmed directly with Electro Med Supply, Inc.