Electro-Nerve Stimulator TENS Model Biomed 2000/A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905570 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 Biomed 2000/A is a transcutaneous electrical nerve stimulation (TENS) device, classified as an electro-nerve stimulator. It delivers low-voltage electrical pulses to the skin’s surface to modulate pain perception via nerve stimulation, adhering to the Neurology advisory committee’s product-code category (GZJ). Designed for non-invasive therapeutic use, it targets chronic or acute pain relief through controlled electrical stimulation.
This device is supplied as a reusable medical instrument, intended for clinical or home use under professional supervision. It operates with adjustable parameters, including pulse width modulation and burst modes, and requires no sterility as it is not implanted or invasive. The FDA 510K clearance (K905570) confirms its compliance with U.S. regulatory standards for electro-nerve stimulators. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and safety.
Frequently asked questions
What is the Biomed 2000/A TENS device used for?
The Biomed 2000/A TENS (Transcutaneous Electrical Nerve Stimulation) device is designed to provide non-invasive pain relief for both chronic and acute conditions. It achieves this by delivering low-voltage electrical pulses to the skin’s surface, which modulate pain perception through nerve stimulation. This method is particularly useful for patients seeking alternative or complementary pain management without invasive procedures.
Is the Biomed 2000/A TENS device single-use or reusable?
The Biomed 2000/A TENS device is intended for reusable clinical or home use under professional supervision. Unlike disposable medical devices, it is built to withstand repeated use while maintaining its functionality, provided it is stored and maintained according to the manufacturer’s guidelines. This design ensures cost-effectiveness and convenience for long-term pain management.
Does the Biomed 2000/A TENS device require sterilization?
No, the Biomed 2000/A TENS device does not require sterilization as it is not an invasive or implanted device. It is designed for surface application only, meaning it does not come into contact with sterile body tissues or cavities. Proper cleaning and maintenance, as outlined by the manufacturer, are sufficient to ensure hygiene and safe operation.
What adjustable features does the Biomed 2000/A TENS device offer?
The Biomed 2000/A TENS device includes adjustable parameters such as pulse width modulation and burst modes. These features allow clinicians or users to customize the electrical stimulation to better target specific pain conditions or patient preferences. Adjusting these settings helps optimize comfort and effectiveness for individual pain management needs.
How should the Biomed 2000/A TENS device be stored?
The Biomed 2000/A TENS device should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture to prevent damage. Proper storage ensures the device remains functional and safe for use. Always follow the manufacturer’s specific guidelines for storage and maintenance to avoid compromising performance or regulatory compliance.
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: TENS Model 2000-T Operation Manual | PDF | Electricity - Scribd, Electro-nerve Stimulator Tens Model Biomed 2000/A, Biomedical Life Systems Tens Unit: Biomed 2000 XL TENS Unit, PDF EMS2000ENG REV L.indd - Electro-Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905570 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedical Life Systems, Inc.
Sources (1)
- FDA 510(k) K905570 24 fields · synced Oct 1, 2026