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Electrical Neuro-muscular Stimulator

by Richards Medical Co., Inc. 510(k)

Active United States

510(k) K840895

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840895 Date24 Apr 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Electrical Neuro-muscular Stimulator is a device that delivers electrical impulses to stimulate nerves and muscles. It is used for therapeutic purposes in physical medicine applications.

This device is manufactured by Richards Medical Co., Inc. and is supplied as a single-use or reusable product. It has FDA 510(k) clearance with product code IPF and model number K840895, authorized on April 24, 1984.

Other devices from Richards Medical Co., Inc.

See all devices from Richards Medical Co., Inc. →

Questions

AI-generated answers, 6 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 Electrical Neuro-muscular Stimulator used for?

    The Electrical Neuro-muscular Stimulator is a device that delivers electrical impulses to stimulate nerves and muscles, used for therapeutic purposes in physical medicine applications.

  • Is the Electrical Neuro-muscular Stimulator single-use or reusable?

    The Electrical Neuro-muscular Stimulator is supplied as either a single-use or reusable product, depending on the specific model and configuration selected by the user.

  • What is the regulatory status of this device?

    The Electrical Neuro-muscular Stimulator has FDA 510(k) clearance with product code IPF and model number K840895, authorized on April 24, 1984, and is classified as substantially equivalent.

  • Who manufactures the Electrical Neuro-muscular Stimulator?

    The Electrical Neuro-muscular Stimulator is manufactured by Richards Medical Co., Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.