MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE - Promax-Libra, Tens Device
510(k) K022405
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022405 | Date12 Aug 2002 | 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- Withdrawn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
- GZJ
- Models / Variants
- Promax-Libra, Tens Device
- 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 Promax-XP, TENS and Microcurrent Device is a Stimulator, Nerve, Transcutaneous, For Pain Relief, designed to deliver low-frequency electrical impulses via electrodes. It includes variants such as the Promax-TENS, Promax-Libra, and Promax-MIC, each configured as a TENS device or microcurrent stimulator. These devices are microprocessor-controlled and portable, intended for managing chronic, post-surgical, or post-traumatic pain through transcutaneous electrical nerve stimulation (TENS) or microcurrent therapy.
The Promax family operates in both home and clinical settings, controlled via seven soft-key buttons and an LCD display. These devices are battery-powered and reusable, with no regulatory indication of sterility requirements. They are classified under product code GZJ and were cleared via an FDA 510(k) modification (K022405) under the Neurology advisory committee. No third-party certification or MRI safety labeling is specified.
Other devices from Rehabilicare, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Promax-XP TENS and Microcurrent Device used for?
The Promax-XP TENS and Microcurrent Device is designed to deliver transcutaneous electrical nerve stimulation (TENS) and microcurrent therapy for managing chronic, post-surgical, or post-traumatic pain. It uses low-frequency electrical impulses via electrodes to help alleviate discomfort in both home and clinical settings.
How is the Promax-XP device controlled and powered?
The Promax-XP device is microprocessor-controlled and operated via seven soft-key buttons with an LCD display for user interaction. It is battery-powered, making it portable for use in various settings without requiring a direct power source.
Are the Promax-TENS, Promax-Libra, and Promax-MIC devices single-use or reusable?
The Promax-TENS, Promax-Libra, and Promax-MIC devices are reusable. They are designed for repeated use in both home and clinical environments, with no regulatory indication of sterility requirements for the device itself.
What distinguishes the Promax-XP variants (TENS, Libra, MIC) from each other?
The Promax-XP variants—Promax-TENS, Promax-Libra, and Promax-MIC—share the same core functionality as a TENS or microcurrent stimulator but may differ in specific configurations, programming options, or additional features tailored for particular pain management needs. The Promax-TENS focuses on traditional TENS therapy, while the Promax-MIC emphasizes microcurrent stimulation.
What regulatory pathway was followed for the Promax-XP device?
The Promax-XP TENS and Microcurrent Device underwent an FDA 510(k) modification process (K022405) and was cleared under the Neurology advisory committee. The clearance was granted as substantially equivalent to a predicate device, with a decision date of August 12, 2002.