Reusable Electrode Pad Comparison

Mega Soft™ Replacement Option for Hospitals and Surgery Centers

Indications For Use:

The OKLand® Patient Return Electrode Pad has the same intended use, similar characteristics, is as safe and effective as the Mega Soft™ line of devices*. Per 510(k) Summary, the Mega Soft™ line is the predicate device(s) for the OKLand® Patient Return Electrode Pad’s FDA Class II Clearance.

OKLand® Patient Return Electrode Pad is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery.

Similarities:

  • Technological Characteristics

  • Materials

  • Physical Specifications

  • Biocompatibility

  • Electrical Safety and Compatibility

  • Bench Performance

Differences:

  • Physical Size(s) & Thickness

  • Capacitance

  • Effective Contacting Area

  • Body Contacting Materials

  • Test results verified the differences do not raise additional safety or effectiveness concerns.
    (per 510(k) - K183148)

Below is a chart that provides a quick catalog reference to help identify the Mega Soft™ line and the closest match to an OKLand® PRE Pad model.

It is for reference only as sizes are not an exact match. We also carry a few additional sizes that you may find beneficial.

* Predicate and Reference Devices:

Predicate Device: MegaSoft Universal Patient Return Electrode (K133726)

Reference device: Mega 2000 Soft Patient Return Electrode Pad (K021077)

Reference Device: Mega 2000 Soft Dual Cord Patient Return Electrode Pad (K031285)

Reference Device: Mega Soft Patient Return Electrode (K080741)