Mentor 402 Transcutaneous Elec. Stimulat
510(k) K803113
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK803113 | Date30 Dec 1980 | 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- Withdrawn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
- 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 Mentor 402 Transcutaneous Electrical Stimulator is a transcutaneous electrical nerve stimulation (TENS) device, classified under product code GZJ. It delivers low-voltage electrical currents through electrodes placed on the skin to modulate pain signals, providing symptomatic relief for chronic or acute pain conditions. Designed for non-invasive use, it targets peripheral nerves to interrupt pain transmission, offering an alternative to pharmacological pain management. The device operates on the principle of electrical stimulation to alleviate discomfort without altering underlying pathology.
This device is supplied as a reusable medical instrument and requires proper handling to ensure safety and efficacy. It is intended for use in clinical, home, or outpatient settings by trained personnel or patients under supervision. The Mentor 402 is cleared by the FDA under 510(k) K803113, with a decision date of December 30, 1980, and falls under the purview of the Neurology Advisory Committee. No specific sterility requirements are noted, but adherence to manufacturer guidelines for cleaning and maintenance is essential to prevent contamination and ensure longevity. The device’s regulatory status is tied to its substantial equivalence determination (SESE) under traditional 510(k) review.
Other devices from George H. Frisch
Questions
AI-generated answers, 1 Oct 2026
What is the Mentor 402 Transcutaneous Electrical Stimulator used for?
The Mentor 402 is designed to provide symptomatic relief for chronic or acute pain conditions by delivering low-voltage electrical currents through electrodes placed on the skin. It works by modulating pain signals via transcutaneous electrical nerve stimulation (TENS), targeting peripheral nerves to interrupt pain transmission without altering the underlying cause of the pain. This makes it useful as an alternative to pharmacological pain management in clinical, home, or outpatient settings.
Is the Mentor 402 a single-use or reusable device?
The Mentor 402 is supplied as a reusable medical instrument. While no specific sterility requirements are explicitly stated, proper cleaning and maintenance are critical to prevent contamination and ensure the device’s safety and longevity. Users must follow manufacturer guidelines to maintain hygiene and functionality.
What regulatory approval does the Mentor 402 hold?
The Mentor 402 Transcutaneous Electrical Stimulator is cleared by the FDA under a traditional 510(k) review process, with the clearance number K803113. The device was determined to be substantially equivalent (SESE) to a legally marketed predicate, and its regulatory status is tied to this determination. The Neurology Advisory Committee reviewed the submission.
Where can the Mentor 402 be used?
This device is intended for use in clinical, home, or outpatient settings. It is designed for trained personnel or patients under supervision, ensuring safe and effective application of transcutaneous electrical stimulation for pain relief. Proper training is essential to maximize benefits and minimize risks.
How should the Mentor 402 be stored and maintained?
While specific storage instructions are not detailed in the provided data, the Mentor 402, being reusable, requires adherence to manufacturer guidelines for cleaning and maintenance. Proper handling and storage will help prevent contamination, ensure device longevity, and maintain its performance for transcutaneous electrical stimulation therapy.