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Electrical Muscle Stimulator

by Nitron Electronics

510(k) K820884

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 NumberK820884 Date29 Apr 1982ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

An electrical muscle stimulator is a powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is designed for various body areas with different intensity settings and massage modes.

The device is supplied by Nitron Electronics and is classified under product code IPF. It is a Class II device cleared by the FDA as substantially equivalent on April 29, 1982, with K number K820884. The device is intended for use in physical medicine.

Questions

AI-generated answers, 27 Sep 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 purpose of the Electrical Muscle Stimulator?

    The Electrical Muscle Stimulator is a powered device designed to repeatedly contract muscles by passing electrical currents through electrodes contacting affected body areas. It is intended for use in physical medicine with various intensity settings and massage modes for different body areas.

  • How is the Electrical Muscle Stimulator supplied?

    The device is supplied by Nitron Electronics and is classified under product code IPF. It is a Class II device that was cleared by the FDA as substantially equivalent on April 29, 1982, with K number K820884.

  • Is the Electrical Muscle Stimulator single-use or reusable?

    The device data does not specify whether the Electrical Muscle Stimulator is single-use or reusable. The information provided focuses on its classification, regulatory clearance, and intended use in physical medicine.

  • What are the available sizes and models of the Electrical Muscle Stimulator?

    The device data does not provide specific information about available sizes or models of the Electrical Muscle Stimulator. The description mentions it is designed for various body areas with different intensity settings and massage modes, but does not detail specific size options or model variations.