Electro-Nerve Stimulator Tens Model Micro Plus-A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K915210 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 Micro Plus-A is a two-channel analog microcurrent electrical nerve stimulator. It is designed to provide microcurrent therapy by utilizing adjustable microamp and milliamp ranges to deliver electrical stimulation.
This portable device features selectable polarity settings including positive, negative, or bipolar, along with clinician-adjustable pulse rate and duration characteristics. The device is authorized via FDA 510k clearance.
Frequently asked questions
What is the Electro-Nerve Stimulator TENS Model Micro Plus-A used for?
The Micro Plus-A is designed for microcurrent electrical nerve stimulation (TENS) therapy. It delivers adjustable microamp and milliamp ranges to stimulate nerves and muscles, helping manage pain or promote tissue healing. The adjustable polarity (positive, negative, or bipolar) and pulse characteristics allow clinicians to tailor stimulation parameters to specific patient needs.
How is the Micro Plus-A supplied, and what does the packaging include?
The device is supplied as a standalone, portable unit. The packaging includes the Micro Plus-A stimulator itself, along with any necessary cables or electrodes (if applicable) for connection. Since it is a two-channel analog device, it may require additional accessories like adhesive electrodes for proper use, though these are not explicitly listed in the specifications.
Is the Electro-Nerve Stimulator TENS Model Micro Plus-A single-use or reusable?
The Micro Plus-A is a reusable device. It is designed for clinical or home use with adjustable settings, meaning it is intended to be used repeatedly across multiple patients or sessions. However, any disposable components (e.g., electrodes) would need to be replaced per clinical protocol.
What regulatory pathway was followed for FDA clearance of this device?
The Micro Plus-A received FDA clearance through a 510(k) Traditional Review process, classified under the Neurology advisory committee (NE). The submission was determined to be Substantially Equivalent (SESE) to a predicate device, with a decision date of May 4, 1992. The clearance type (K915210) and product code (GZJ) further categorize its regulatory classification.
Does the device require any special storage conditions?
The specifications do not explicitly mention special storage requirements, but as an electronic medical device, it should be stored in a clean, dry environment protected from extreme temperatures, moisture, and physical damage. If the device includes rechargeable batteries, they should be stored according to manufacturer guidelines to maintain functionality.
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: Micro Plus® - Microcurrent - BMLS, Micro Plus Microcurrent Stimulator | MENS KMICP |…, Micro Plus™ - Analog Microcurrent Stimulator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K915210 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedical Life Systems, Inc.
Sources (1)
- FDA 510(k) K915210 24 fields · synced Oct 1, 2026