Electro-Nerve Stimulator TENS Model Systems 2000/A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905377 FDA 510(k)
- FDA Product Code
- GZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Electro-Nerve Stimulator TENS Model Systems 2000/A is a transcutaneous electrical nerve stimulation device used for pain management. It delivers electrical impulses through the skin to stimulate nerves and alleviate pain.
This device is supplied by Biomedical Life Systems, Inc. and has FDA 510(k) clearance with product code GZJ. It is designed for single-use or multiple applications depending on the specific model configuration and is intended for use in clinical settings under healthcare professional supervision.
Frequently asked questions
What is the Electro-Nerve Stimulator TENS Model Systems 2000/A used for?
The Electro-Nerve Stimulator TENS Model Systems 2000/A is a transcutaneous electrical nerve stimulation device used for pain management. It delivers electrical impulses through the skin to stimulate nerves and alleviate pain in clinical settings under healthcare professional supervision.
How is the Electro-Nerve Stimulator TENS Model Systems 2000/A supplied?
The device is supplied by Biomedical Life Systems, Inc. It is designed for single-use or multiple applications depending on the specific model configuration. The exact supply details would be provided by the manufacturer based on the selected model.
What is the regulatory status of the Electro-Nerve Stimulator TENS Model Systems 2000/A?
The Electro-Nerve Stimulator TENS Model Systems 2000/A has FDA 510(k) clearance with product code GZJ. It was determined to be substantially equivalent to predicate devices through the traditional clearance process, with the review handled by the Neurology advisory committee.
Can the Electro-Nerve Stimulator TENS Model Systems 2000/A be reused?
The device is designed for single-use or multiple applications depending on the specific model configuration. The reusability would be determined by the particular model selected and its design specifications, which should be confirmed with the manufacturer.
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: Electro-nerve Stimulator Tens Model Systems 2000/A, Electro-nerve Stimulator Tens Model Biomed 2000/A, TENS Model 2000-T Operation Manual | PDF | Electricity - Scribd, ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A… - FDA.report, [Sale] EMS 2000 Electrical Muscle Stimulator | Vitality Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905377 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedical Life Systems, Inc.
Sources (1)
- FDA 510(k) K905377 24 fields · synced Oct 1, 2026