Tenzcare Muscle Stimulation Electrodes
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K831104 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 Tenzcare Muscle Stimulation Electrodes are cutaneous electrodes designed for use in muscle stimulation applications. These devices function as a component within a neurology-related system to facilitate electrical stimulation.
This device is identified under product code GXY and is regulated as a Class II medical device. It received FDA 510(k) clearance under K831104 on May 9, 1983.
Frequently asked questions
What are Tenzcare Muscle Stimulation Electrodes used for?
These cutaneous electrodes are designed to function as a component within a neurology-related system to facilitate electrical stimulation for muscle stimulation applications.
What is the regulatory status of these electrodes?
The Tenzcare Muscle Stimulation Electrodes are regulated as a Class II medical device and received FDA 510(k) clearance under K831104 on May 9, 1983.
How are these electrodes classified by the FDA?
These devices are identified under product code GXY and fall under the oversight of the Neurology advisory committee, having been determined to be substantially equivalent to existing devices.
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: TENZCARE MUSCLE STIMULATION ELECTRODES - Innolitics, K831104 - TENZCARE MUSCLE STIMULATION ELECTRODES | FDA 510(k), Tenzcare Muscle Stimulation Electrodes 510(k) K831104 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831104 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K831104 24 fields · synced Sep 22, 2026