MODEL7500 Microcurrent Tens Device, Mct-F5, Mct-F50, Mct-F500

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

510(k) Number

K013167 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• What are the key differences between the MCT-F5, MCT-F50, and MCT-F500 models of the Model 7500 Microcurrent TENS Device, and how do they affect clinical use?

  The Model 7500 Microcurrent TENS Device comes in three variants—MCT-F5, MCT-F50, and MCT-F500—each offering distinct output levels determined by internal component configurations. These differences allow clinicians to select the appropriate model based on patient needs, as the output intensity varies to modulate nerve signals for pain management. The specific configurations ensure compliance with the device’s intended use for chronic intractable pain relief in clinical neurology settings.

• How is the Model 7500 Microcurrent TENS Device supplied, and are there any special handling or storage requirements?

  The Model 7500 Microcurrent TENS Device is supplied as a standalone, reusable unit with no software dependency. It does not require specialized storage conditions beyond standard environmental parameters, meaning it can be stored in typical clinical settings without additional precautions. Since it is non-software-dependent and has no MRI safety considerations, it can be safely used and stored alongside other standard medical equipment.

• Is the Model 7500 Microcurrent TENS Device intended for use in specific clinical settings, and what type of regulatory clearance does it hold?

  The Model 7500 Microcurrent TENS Device is specifically designed for use in clinical neurology settings, as indicated by its classification as a Class II medical device under FDA regulations. It holds FDA 510(k) clearance (K013167) through a Substantially Equivalent (SESE) decision by the Neurology Advisory Committee, confirming its compliance for pain management applications in these specialized environments.

• How does the Model 7500 Microcurrent TENS Device work, and what type of pain relief does it provide?

  The Model 7500 Microcurrent TENS Device delivers microcurrent pulses through electrodes applied to the patient’s skin, modulating nerve signals to provide symptomatic relief of chronic intractable pain. By targeting nerve pathways, it helps alleviate pain sensations without altering the underlying cause, making it suitable for long-term management in clinical neurology settings.

• Can the Model 7500 Microcurrent TENS Device be reused, and are there any limitations on its use in clinical environments?

  Yes, the Model 7500 Microcurrent TENS Device is designed for reuse, as it is a non-disposable, non-software-dependent unit with discrete electronic components. Since it lacks MRI safety considerations, it can be safely used in clinical environments where MRI machines are present. However, adherence to standard infection control protocols is recommended for reusable medical devices to ensure patient safety.