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RT300-SL, Model FA100052; RT300-SLSA, Model FA104581

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K090750

by Restorative Therapies, Inc.

Identifiers

510(k) Number
K090750 FDA 510(k)
FDA Product Code
GZI FDA 510(k)
Models / Variants
Rt300-Sl, Model Fa100052 FDA 510(k)EUDAMED
Rt300-Slsa, Model Fa104581 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5810 FDA 510(k)
Regulation Number
882.5810 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RT300-SL and RT300-SLSA are External Functional Neuromuscular Stimulators, designed to provide functional electrical stimulation (FES) therapy. These devices deliver targeted electrical impulses to neuromuscular pathways, aiding in muscle activation and movement for patients with neurological conditions such as spinal cord injury, stroke, or multiple sclerosis.

These devices are intended for clinical and home use, supplied as reusable medical equipment. They are classified as Class II devices under FDA regulations (882.5810) and have received FDA 510(k) clearance and MDD authorization. The RT300-SL and RT300-SLSA are intended for use in settings where neuromuscular stimulation is administered under professional supervision or patient self-management, with no specific MRI safety restrictions stated.

Frequently asked questions

Are the RT300-SL and RT300-SLSA devices intended for single-use or can they be reused in clinical or home settings?

The RT300-SL and RT300-SLSA are explicitly described as reusable medical equipment, suitable for both clinical and home use. Since they are classified as reusable devices, they are designed for repeated use under professional supervision or patient self-management, provided proper maintenance and cleaning protocols are followed.

What types of neurological conditions are these devices intended to assist with, and how do they work?

These devices are designed to provide functional electrical stimulation (FES) therapy for patients with neurological conditions such as spinal cord injury, stroke, or multiple sclerosis. They deliver targeted electrical impulses to neuromuscular pathways, helping to activate muscles and facilitate movement where voluntary control may be impaired.

What regulatory pathways have these devices undergone, and what does that mean for their use?

The RT300-SL and RT300-SLSA have received FDA 510(k) clearance and MDD authorization, confirming they meet regulatory standards for safety and effectiveness. The FDA classification under 882.5810 as Class II devices indicates they undergo additional scrutiny beyond general controls, ensuring they are suitable for their intended use in neuromuscular stimulation under professional or self-managed care.

Are there any specific storage requirements or considerations for these devices?

While the provided data does not specify exact storage conditions, as reusable medical equipment, these devices should be stored in a clean, dry environment to prevent contamination or damage. Proper maintenance, including cleaning and calibration, is essential to ensure their continued functionality and safety for repeated use.

What is the difference between the RT300-SL and RT300-SLSA models, and which one might be more suitable for a specific patient?

The data does not explicitly detail functional differences between the RT300-SL (Model FA100052) and RT300-SLSA (Model FA104581), but the inclusion of separate model numbers suggests potential variations in features, settings, or intended applications. Clinicians or patients should consult the manufacturer’s documentation or a healthcare provider to determine which model aligns best with their specific needs, such as stimulation intensity, electrode compatibility, or user interface preferences.

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: Rt300-sl, Model Fa100052; Rt300-slsa, Model Fa104581 (K090750) — Fda ..., RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581… - FDA.report, www.accessdata.fda.gov, RT300 - Leg | Arm | Core - Restorative Therapies

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Restorative Therapies, Inc.

Sources (2)

  • FDA 510(k) K090750 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026