Dynatron 438

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

510(k) Number

K870515 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• What is the Dynatron 438 used for in clinical settings?

  The Dynatron 438 is a physical medicine device designed for therapeutic applications in physical rehabilitation. It is specifically intended for muscle stimulation, nerve stimulation, or electrotherapy to help manage pain, strengthen muscles, or aid recovery from injuries or neurological conditions. Clinicians use it to deliver controlled electrical impulses for targeted therapeutic effects.

• Is the Dynatron 438 reusable or single-use?

  The Dynatron 438 is supplied as a reusable medical instrument. Unlike single-use devices, it is intended for repeated use in clinical settings after proper cleaning and maintenance. This design allows for cost-effective deployment in environments where electrotherapy is frequently administered.

• Does the Dynatron 438 require sterilization before use?

  The provided data does not specify any sterility requirements for the Dynatron 438. Since it is classified as a reusable device, standard infection control protocols—such as cleaning and disinfection—should be followed between uses to ensure patient safety. Always adhere to facility-specific guidelines for reprocessing electrotherapy equipment.

• What regulatory pathway was followed for FDA clearance of the Dynatron 438?

  The Dynatron 438 received FDA clearance under the Traditional 510(k) pathway, determined to be substantially equivalent to a legally marketed predicate device. The decision was made by the Physical Medicine advisory committee on June 16, 1987, following a review process initiated on February 5, 1987. This pathway ensures compliance with existing standards for electrotherapy devices.

• Are there any documented safety considerations for MRI use with the Dynatron 438?

  The provided data does not include any information regarding the MRI safety of the Dynatron 438. If MRI compatibility is required for patients, clinicians should consult the manufacturer’s updated documentation or guidelines to ensure safe use in magnetic resonance environments. Always prioritize patient safety when determining device suitability.