A-Tens - Model Ai-87
510(k) K864735
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864735 | Date20 Feb 1987 | 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- Withdrawn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, 6 Oct 2026
The A-TENS - MODEL AI-87 is a transcutaneous nerve stimulator for pain relief, classified under the Neurology specialty with product code GZJ. It is a medical device that delivers electrical stimulation through the skin to modulate nerve activity for therapeutic purposes.
This device received FDA 510(k) clearance as substantially equivalent (K864735) on February 20, 1987, following a traditional review process. It is manufactured by American Imex and is intended for use in clinical settings where transcutaneous electrical nerve stimulation is indicated for pain management.
Other devices from American Imex
Questions
AI-generated answers, 6 Oct 2026
What is the A-TENS - MODEL AI-87 used for?
The A-TENS - MODEL AI-87 is a transcutaneous nerve stimulator designed for pain relief. It delivers electrical stimulation through the skin to modulate nerve activity for therapeutic purposes, specifically indicated in clinical settings where transcutaneous electrical nerve stimulation is used for pain management.
How is the A-TENS - MODEL AI-87 supplied and is it reusable?
The device data does not specify supply format, sterility, or whether the A-TENS - MODEL AI-87 is single-use or reusable. Therefore, no details about its supply, sterility, or reuse can be provided based on the available information.
What regulatory pathway was used for the A-TENS - MODEL AI-87?
The A-TENS - MODEL AI-87 received FDA 510(k) clearance through a traditional review process. It was determined to be substantially equivalent to a predicate device, with clearance granted on February 20, 1987, under K864735.