Electric Muscle Stimulator (K813533)

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

Full name

Electric Muscle Stimulator

510(k) Number

K813533 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Monitor, Myo, Model J3

  Class II

  FDA 510(k) K770252 Active Cleared 18 Feb 1977

• Model EM-IR

  Class II

  FDA 510(k) K810528 Active Cleared 31 Mar 1981

• Testcorp Ra

  Class II

  FDA 510(k) K831364 Active Cleared 27 May 1983

• J4 Myo-Monitor

  Class II

  FDA 510(k) K842223 Active Cleared 19 Nov 1984

• Bns 40

  Class II

  FDA 510(k) K842224 Active Cleared 19 Nov 1984

• Model Em-2 Bioelectric Processor

  Class II

  FDA 510(k) K830034 Active Cleared 9 Feb 1983

See all devices from Myo-Tronics Research, Inc. →

• What is the K813533 Electric Muscle Stimulator used for?

  The K813533 Electric Muscle Stimulator is a neuromuscular electrical stimulation (NMES) device designed to induce muscle contractions through controlled electrical impulses applied via surface electrodes. It is intended for therapeutic use in clinical and home settings to support muscle activation, relaxation, or pain relief. Common applications include rehabilitation, muscle strengthening, and temporary relief of neuromuscular conditions, such as those seen in physical therapy or dental neuromuscular treatments. The device avoids invasive procedures by delivering stimulation externally.

• Is the K813533 Electric Muscle Stimulator reusable or single-use?

  The K813533 Electric Muscle Stimulator is supplied as a reusable device. It is not intended for single-use and is designed for repeated use in clinical or home environments, provided it is maintained according to manufacturer guidelines. Reusability is supported by its durable construction and non-sterile classification, which aligns with its intended use in professional settings like physical therapy or patient self-management under guidance.

• What are the key specifications for storage and use of the K813533?

  The K813533 Electric Muscle Stimulator requires no special storage conditions beyond protection from moisture and physical damage. It operates on battery power, so ensure batteries are properly installed and replaced as needed. The device is not sterile and is intended for non-invasive use only. Always follow manufacturer instructions for electrode application, electrical parameter adjustments, and device maintenance to ensure safe and effective operation.

• Does the K813533 Electric Muscle Stimulator have any MRI safety restrictions?

  The K813533 Electric Muscle Stimulator does not specify any MRI safety restrictions in its documentation. However, since it is an electrical device with conductive components, it should not be used in or near an MRI environment unless explicitly cleared for such use by the manufacturer. Always verify compatibility with MRI systems before use in a clinical setting where MRI procedures are performed.

• How does the K813533 Electric Muscle Stimulator differ from other neuromuscular stimulation devices?

  The K813533 Electric Muscle Stimulator is distinguished by its FDA 510(k) clearance (K813533) under the Physical Medicine advisory committee, indicating it meets established safety and performance standards for neuromuscular stimulation. It is designed for adjustable electrical parameters to safely modulate muscle responses, making it versatile for clinical and home use in applications like physical therapy, dental neuromuscular treatments, or patient self-management. Its reusable, non-sterile nature also sets it apart from single-use or sterile alternatives.