Progenix Select Stim
510(k) K242460
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242460 | Date2 Apr 2025 | 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- Withdrawn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
- NUH
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Progenix Select Stim is a two-channel Transcutaneous Electrical Nerve Stimulation (TENS) device, designed to deliver biphasic, rectangular electrical pulses for symptomatic pain relief. It falls under the classification of neuromodulation devices, providing non-invasive electrical stimulation to target muscle pain through self-adhesive electrodes applied to the skin. The device is intended for at-home use and operates via a portable, battery-powered (9V) system, allowing for flexible and accessible pain management.
Supplied as a reusable device, the Progenix Select Stim is cleared for use under FDA 510(k) (K242460) with a Traditional review pathway, classified under the Neurology advisory committee. It is intended for over-the-counter application and does not require MRI safety considerations. The device is manufactured by Progenix, LLC, based in Fairfax, Virginia, and includes model-specific electrodes (K160138) for proper functionality. No additional sterility or single-use requirements are specified.
Questions
AI-generated answers, 1 Oct 2026
What is the Progenix Select Stim used for?
The Progenix Select Stim is a two-channel Transcutaneous Electrical Nerve Stimulation (TENS) device designed to provide symptomatic pain relief for muscle pain. It achieves this through non-invasive electrical stimulation delivered via self-adhesive electrodes placed on the skin. The device is intended for at-home use and is particularly suited for individuals seeking flexible, accessible pain management without the need for professional administration.
How is the Progenix Select Stim supplied and powered?
The Progenix Select Stim is supplied as a reusable device, meaning it is designed for repeated use over time. It operates on a portable, battery-powered system using a 9V battery, which allows for convenient and flexible use in various settings, such as home or office. The battery-powered design ensures mobility without the need for constant access to electrical outlets.
Are there any sterility or single-use requirements for the Progenix Select Stim?
No additional sterility or single-use requirements are specified for the Progenix Select Stim device itself. However, the device includes model-specific electrodes (K160138) that are intended for reusable application, provided they are used according to the manufacturer’s guidelines. Proper hygiene practices, such as cleaning the electrodes and skin before each use, are recommended to ensure safe and effective operation.
What models or sizes of electrodes are compatible with the Progenix Select Stim?
The Progenix Select Stim is designed to work with model-specific electrodes identified as K160138. These electrodes are self-adhesive and intended for application directly to the skin to deliver the electrical stimulation. The device does not specify multiple sizes of electrodes, so the K160138 model is the standard for proper functionality and pain relief targeting.
How should the Progenix Select Stim be stored, and are there any special considerations?
The Progenix Select Stim should be stored in a clean, dry place away from direct sunlight, extreme temperatures, and moisture to maintain its functionality. Since it is battery-powered, it is advisable to store the device with the battery properly inserted or removed as per the manufacturer’s instructions to prevent battery drain or corrosion. Additionally, the reusable electrodes should be stored in a way that avoids contamination and damage to their adhesive properties.