MD-104 Powered Muscle Stimulator

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

510(k) Number

K872206 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Ms-179 Electronic Muscle Stimulator

  Class II

  FDA 510(k) K862485 Active Cleared 16 Jul 1986

• Ms-159 Electronic Muscle Stimulator

  Class II

  FDA 510(k) K862486 Active Cleared 16 Jul 1986

• Ms-189 Muscle Stimulator

  Class II

  FDA 510(k) K854801 Active Cleared 27 Mar 1986

• Tens-It

  Class II

  FDA 510(k) K933368 Active Cleared 7 Jun 1994

• Ms-108, Powered Muscle Stimulator

  Class II

  FDA 510(k) K872207 Active Cleared 6 Oct 1987

• Ms-112, Powered Muscle Stimulator

  Class II

  FDA 510(k) K872208 Active Cleared 6 Oct 1987

See all devices from Electro Med Supply, Inc. →

• What types of therapeutic uses is the MD-104 Powered Muscle Stimulator intended for in physical medicine applications?

  The MD-104 is designed for therapeutic muscle stimulation, which involves repeatedly contracting muscles using electrical currents delivered through electrodes placed on the target body area. This is commonly used in physical medicine to aid muscle re-education, reduce atrophy, or alleviate pain by promoting blood flow and muscle activity.

• Is the MD-104 a single-use or reusable device, and how should it be handled between patients?

  The MD-104 is explicitly supplied as a reusable medical instrument. Since it is not labeled as sterile or single-use, proper cleaning and disinfection protocols must be followed between uses to ensure patient safety and device longevity.

• How was the MD-104’s regulatory approval determined, and what does that mean for its use?

  The MD-104 received FDA clearance under the Traditional 510(k) review pathway in 1987 (K872206) and was classified as Substantially Equivalent (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously approved device, ensuring compliance with FDA standards for muscle stimulators in physical medicine.

• What is the manufacturer’s address and contact information for the MD-104 Powered Muscle Stimulator?

  The manufacturer, Electro Med Supply, Inc., is located at P.O. Drawer 179, 19207 Jayhawk Dr., Penn Valley, CA 95946. For inquiries, the contact listed is THOMAS V DAIGLE.