Neuromuscular Stimulator 3105
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K840467 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neuromuscular Stimulator 3105 is a powered device classified as a Stimulator, Muscle, designed to deliver electrical stimulation for neuromuscular applications. It is intended for use in physical medicine to facilitate muscle contraction through controlled electrical impulses, aiding in rehabilitation, pain management, or functional recovery. The device operates via external electrical stimulation to stimulate peripheral nerves and muscles, promoting therapeutic outcomes in clinical settings.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K840467) with a classification under Stimulator, Muscle, Powered. It is intended for use in clinical environments where neuromuscular stimulation is required, with no specific sterility requirements stated in the data. The device is not MRI-safe, and no additional size or storage specifications are provided beyond its model designation. Authorisation was granted under the Physical Medicine advisory committee in 1984.
Frequently asked questions
What is the Neuromuscular Stimulator 3105 used for?
The Neuromuscular Stimulator 3105 delivers controlled electrical impulses to stimulate peripheral nerves and muscles, facilitating muscle contraction. It is primarily used in physical medicine to aid rehabilitation, manage pain, or restore function in clinical settings where neuromuscular stimulation is required.
Is the Neuromuscular Stimulator 3105 reusable or single-use?
This device is designed as a reusable medical instrument. It is intended for repeated use in clinical environments, though proper cleaning and maintenance protocols must be followed to ensure safety and efficacy between uses.
What regulatory approval does the Neuromuscular Stimulator 3105 hold?
The device holds FDA 510(k) clearance under the classification of a powered muscle stimulator, with the clearance number K840467. It was granted under the Physical Medicine advisory committee in 1984, with a determination of substantial equivalence to prior devices.
Are there any sterility requirements for the Neuromuscular Stimulator 3105?
The provided data does not specify any sterility requirements for this device. Since it is reusable, it is intended to be cleaned and maintained according to clinical protocols rather than being sterile upon use.
Can the Neuromuscular Stimulator 3105 be used in MRI environments?
No, the Neuromuscular Stimulator 3105 is not MRI-safe. If used in proximity to MRI equipment, it could pose risks to both the device and the patient, so caution and proper protocols must be followed.
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: Neurovascular Products | Medtronic, Neuromuscular Stimulator 3105 510 (k) K840467 - FDA.report, SPINAL CORD STIMULATORS - Medtronic, Medtronic, Inc.: Vascular & IR Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K840467 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K840467 24 fields · synced Oct 5, 2026