ION Magnum Genius
510(k) K123158
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123158 | Date21 Jun 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ION Magnum Genius is a Powered Muscle Stimulator (product code NGX), designed to deliver controlled electrical stimulation for muscle conditioning. It operates via six independent channels, applying biphasic, rectangular electrical pulses to targeted muscle groups through self-adhesive electrodes. This device is classified under Class II with Special Controls and is intended for use in clinical settings by healthcare professionals. Its primary function is to facilitate muscle activation and rehabilitation through precise, adjustable stimulation parameters.
The device is supplied as a reusable, non-sterile medical instrument, intended for use in outpatient or clinical environments. It requires no special storage conditions beyond standard operating room or treatment room environments. The ION Magnum Genius was granted FDA 510(k) clearance under the Physical Medicine (PM) advisory committee, with a decision date of June 21, 2013. No specific MRI safety classification or sterility requirements are noted in the regulatory submission.
Other devices from Ion Genius, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the ION Magnum Genius used for?
The ION Magnum Genius is a Powered Muscle Stimulator designed to activate and rehabilitate muscles through controlled electrical stimulation. It uses six independent channels to apply biphasic, rectangular pulses to targeted muscle groups via self-adhesive electrodes. This makes it ideal for clinical muscle conditioning and recovery programs, particularly in outpatient or treatment environments where precise stimulation parameters are required.
Is the ION Magnum Genius reusable or single-use?
The ION Magnum Genius is a reusable device, intended for repeated use in clinical settings. It is classified as non-sterile, meaning it does not require sterilization between uses but must be cleaned and maintained according to manufacturer guidelines to ensure safety and functionality.
What storage conditions are required for the ION Magnum Genius?
No special storage conditions are specified for the ION Magnum Genius beyond standard operating room or treatment room environments. It should be stored in a clean, dry location away from direct sunlight or extreme temperatures to preserve its functionality and longevity.
How many channels does the ION Magnum Genius have, and what type of pulses does it deliver?
The ION Magnum Genius features six independent channels, each capable of delivering biphasic, rectangular electrical pulses. This design allows for simultaneous or sequential stimulation of multiple muscle groups with adjustable parameters, enhancing flexibility for rehabilitation or conditioning protocols.
What regulatory pathway was followed for the ION Magnum Genius?
The ION Magnum Genius received FDA 510(k) clearance under the Physical Medicine (PM) advisory committee, demonstrating it is substantially equivalent to a legally marketed device. The clearance was granted on June 21, 2013, following a traditional review process. This classification ensures it meets regulatory standards for safety and effectiveness in clinical muscle stimulation applications.