Identifiers
- 510(k) Number
- K072553 FDA 510(k)
- FDA Product Code
- NGX 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 System-Arms Model 390, E60 is a two-channel, battery-powered transcutaneous electrical muscle stimulation (TENS/EMS) device classified as a physical medicine device. It delivers controlled electrical impulses to stimulate muscle contraction, designed for non-invasive therapeutic use in the arm muscles.
This device is supplied as a home-use system, including a handheld control unit, two arm garments (left and right), four adhesive gel-based electrodes, and instructional materials. It is intended for single-use per electrode pack and requires no sterilisation, with no specific MRI safety restrictions noted. The device carries an FDA 510(k) clearance under product code NGX and advisory committee review for Physical Medicine.
Frequently asked questions
What is the System-Arms Model 390, E60 primarily used for in clinical settings?
The System-Arms Model 390, E60 is designed for non-invasive transcutaneous electrical muscle stimulation (TENS/EMS) of the arm muscles. It delivers controlled electrical impulses to stimulate muscle contraction, typically used in physical medicine for therapeutic purposes like improving muscle tone, reducing atrophy, or aiding rehabilitation after injury or surgery.
How is the System-Arms Model 390, E60 supplied, and what components are included?
The System-Arms Model 390, E60 is supplied as a home-use system, including a handheld control unit, two arm garments (one for the left arm and one for the right), four adhesive gel-based electrodes, and instructional materials. This setup is intended for single-use per electrode pack, ensuring hygiene and ease of use.
Is the System-Arms Model 390, E60 reusable, and if not, how should the electrodes be managed?
The System-Arms Model 390, E60 is designed for single-use per electrode pack. The adhesive gel-based electrodes are not meant to be reused, so each pack should be discarded after one use to maintain sterility and prevent cross-contamination. The handheld control unit and arm garments, however, can be reused for subsequent treatments.
What regulatory pathway was followed for the FDA clearance of the System-Arms Model 390, E60?
The System-Arms Model 390, E60 received FDA clearance through a traditional 510(k) process, specifically under product code NGX for Physical Medicine devices. The device was reviewed by the Physical Medicine (PM) advisory committee and was determined to be substantially equivalent to a legally marketed predicate device.
Are there any special considerations for storage or use of the System-Arms Model 390, E60, such as MRI safety?
The System-Arms Model 390, E60 does not have specific MRI safety restrictions noted in its documentation. However, since it is a battery-powered electrical device, it should not be used near MRI equipment unless explicitly cleared for such use by the manufacturer. Storage should follow general guidelines for electrical medical devices, keeping it in a dry, clean environment away from extreme temperatures.
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: SYSTEM-ARMS, MODEL 390,E60 (K072553) — FDA 510(k) | Innolitics, PDF <0 7265? - accessdata.fda.gov, SYSTEM-ARMS, MODEL 390,E60 (K072553) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072553 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K072553 24 fields · synced Sep 19, 2026