Physiometrix Cable Adapter Modification

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

510(k) Number

K935260 ↗

FDA Product Code

IKD

Device Class

Class II

Regulation

21 CFR Part 890.1175

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Sedline Sedation Monitor with Frontal Psi and Sedtrace EEG Electrose Set

  Class II

  FDA 510(k) K051874 Active Cleared 2 Sep 2005

• Model 1320, Neurolink II Neuromonitoring System

  Class II

  FDA 510(k) K970942 Active Cleared 2 Jun 1997

• Model 4310 PSARRAY2 EEG Electrode

  Class II

  FDA 510(k) K020670 Active Cleared 8 Oct 2002

• Model 1210, Medium E-Net

  Class II

  FDA 510(k) K960873 Active Cleared 26 Apr 1996

• Equinox Digital EEG System

  Class II

  FDA 510(k) K962447 Active Cleared 12 Dec 1996

• Model 1700, Hydro Prep

  Class II

  FDA 510(k) K970694 Active Cleared 14 May 1997

See all devices from Physiometrix, Inc. →

• What clinical scenarios would this cable adapter modification be used for in a physical medicine setting?

  This cable adapter modification is designed for clinical settings where existing electrode cables need adjustment or extension to ensure proper compatibility with physiological monitoring systems. It’s particularly useful when cables are too short, damaged, or incompatible with specific monitoring equipment, allowing clinicians to adapt them for accurate and reliable patient monitoring in physical therapy, rehabilitation, or other physical medicine applications.

• Is this a single-use or reusable device, and how should it be handled between uses?

  This is a reusable modification kit, meaning it can be used multiple times across different patients or applications. Since it’s intended for clinical settings, proper cleaning and maintenance between uses are essential to prevent contamination and ensure functionality. Follow standard disinfection protocols for reusable medical devices, such as those recommended by your facility’s infection control guidelines.

• What does the FDA’s 510(k) clearance under the Physical Medicine classification mean for its use in my practice?

  The FDA clearance under the 510(k) pathway with a Substantially Equivalent (SESE) determination means this device has been reviewed and deemed comparable to a legally marketed predicate device in the Physical Medicine category. This clearance does not imply any specific clinical indication but confirms the device meets regulatory standards for safety and effectiveness as an electrode cable modification. Always follow your facility’s policies and local regulations when integrating new devices into patient care.

• How do I determine if this adapter is compatible with my existing electrode cables or monitoring systems?

  The adapter is specifically designed to modify and adapt *existing* electrode cables for compatibility with physiological monitoring systems, but compatibility depends on the original cable specifications and the monitoring equipment’s input requirements. Check your manufacturer’s documentation for the cables and monitoring system to ensure the adapter’s connectors and dimensions align. If unsure, consult the device’s instructions for use or contact Physiometrix support for guidance on specific cable types.