Identifiers
- 510(k) Number
- K140586 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ascend Electrode is a transcutaneous electrical nerve stimulation device. It is intended for the temporary relief of pain associated with sore and aching muscles in the lower extremities resulting from strain due to exercise or normal household and work activities.
This device is subject to federal law, which restricts its use to a physician or other properly licensed practitioner. It is identified under FDA 510(k) clearance K140586. The product is manufactured by NeuroMetrix, Inc.
Frequently asked questions
What is the intended use of the Ascend Electrode?
The Ascend Electrode is a transcutaneous electrical nerve stimulation device designed to provide temporary relief of pain in the lower extremities. It specifically targets sore and aching muscles caused by strain from exercise, household chores, or work-related activities.
Who is authorized to use this device?
Under federal law, the use of the Ascend Electrode is restricted to a physician or another properly licensed practitioner. This ensures that the application of the transcutaneous electrical nerve stimulation is managed by qualified medical personnel.
What is the regulatory status of this device?
The Ascend Electrode is identified under FDA 510(k) clearance K140586. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEUROMETRIX ASCEND USER MANUAL Pdf Download | ManualsLib, Neurometrix ASCEND Manuals | ManualsLib, ASCEND by NEUROMETRIX, INC. | FDA 510 (k) Summary, Ascend Electrode 510 (k) FDA Premarket Notification K140586 NEUROMETRIX ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140586 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurometrix, Inc.
Sources (1)
- FDA 510(k) K140586 24 fields · synced Sep 23, 2026