Truwave
by Dan Med, Inc. 510(k)
Active
510(k) K013210
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013210 | Date4 Apr 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GZJ
- 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 TruWave is a transcutaneous electrical nerve stimulator (TENS), classified under product code GZJ. It delivers controlled electrical impulses via electrodes applied to the skin to modulate nerve activity, providing symptomatic relief for chronic, posttraumatic, and post-surgical pain conditions. Designed for non-invasive use, it targets peripheral nerves to interrupt pain signals, offering an alternative to pharmacological pain management.
Supplied as a reusable device, the TruWave is intended for clinical and home use under medical supervision. It requires no special sterility measures beyond standard electrode preparation and skin cleansing. The device is regulated under FDA 510(k) clearance (K013210) with a Substantially Equivalent (SE) determination, adhering to U.S. regulatory standards for electrical stimulation devices. No specific MRI safety or single-use requirements are noted in its specifications.
Other devices from Dan Med, Inc.
Questions
AI-generated answers, 1 Oct 2026
What conditions is the TruWave TENS device designed to treat?
The TruWave is specifically designed to provide symptomatic relief for chronic pain, posttraumatic pain, and post-surgical pain. It works by delivering controlled electrical impulses via electrodes to modulate nerve activity, interrupting pain signals at the peripheral level. This non-invasive approach offers an alternative to medication-based pain management for these conditions.
Is the TruWave device single-use or reusable?
The TruWave is supplied as a reusable device, intended for both clinical and home use under medical supervision. Unlike single-use devices, it is built for repeated use, provided it is maintained according to manufacturer guidelines and standard electrode preparation protocols.
What sterility measures are required for the TruWave?
The TruWave does not require specialized sterility measures beyond standard electrode preparation and thorough skin cleansing before application. Since it is a reusable device, electrodes should be cleaned and stored properly between uses to ensure hygiene and functionality.
Is the TruWave safe for use in an MRI environment?
The specifications for the TruWave do not explicitly mention MRI safety, so its use in an MRI environment is not recommended unless confirmed by the manufacturer. Always verify compatibility with the specific MRI system and consult the device’s instructions for safe use.
How is the TruWave regulated in the U.S.?
The TruWave is regulated under the FDA’s 510(k) clearance process, with a clearance number of K013210. It received a Substantially Equivalent (SE) determination from the Neurology Advisory Committee, meaning it is deemed comparable to a legally marketed predicate device in terms of safety and effectiveness for its intended use as a transcutaneous electrical nerve stimulator.