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RT300-S, Model FA100052; RT300-SP, Model FA100053

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K060032

by Restorative Therapies, Inc.

Identifiers

510(k) Number
K060032 FDA 510(k)
FDA Product Code
GZI FDA 510(k)
Models / Variants
Rt300-S, Model Fa100052 FDA 510(k)EUDAMED
Rt300-Sp, Model Fa100053 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-S and RT300-SP are External Functional Neuromuscular Stimulators, classified under FDA code GZI and regulation number 882.5810. These devices deliver electrical stimulation to facilitate muscle activation, aiding in functional recovery for neurological conditions such as spinal cord injury, stroke, or multiple sclerosis.

Supplied as reusable medical devices, the RT300-S and RT300-SP are intended for clinical and home use under professional supervision. They hold FDA 510(k) clearance and comply with the Medical Devices Directive (MDD), with no third-party involvement in distribution. Storage and operational settings are not specified in the regulatory data, but adherence to manufacturer guidelines is required for safe use.

Frequently asked questions

What conditions are the RT300-S and RT300-SP neuromuscular stimulators designed to help with in clinical practice?

The RT300-S and RT300-SP are External Functional Neuromuscular Stimulators intended to facilitate muscle activation for patients with neurological conditions like spinal cord injury, stroke, or multiple sclerosis. They are classified under FDA code GZI and regulation 882.5810, with a focus on aiding functional recovery through electrical stimulation.

Are the RT300-S and RT300-SP devices single-use or reusable, and how does this affect their clinical use?

The RT300-S and RT300-SP are explicitly described as reusable medical devices, allowing for both clinical and home use under professional supervision. This design supports long-term therapy and cost efficiency, though proper cleaning and maintenance per manufacturer guidelines are essential to ensure safe and effective reuse.

What regulatory pathways have the RT300-S and RT300-SP followed, and how does this impact their distribution?

The RT300-S and RT300-SP hold FDA 510(k) clearance (K060032) and comply with the Medical Devices Directive (MDD), with no third-party involvement in distribution. This means they are legally authorized for use in the U.S. and EU markets, though adherence to local regulations and manufacturer instructions remains critical for safe operation.

How do I determine the correct model for my patient’s needs, given the RT300-S and RT300-SP options?

The RT300-S (Model FA100052) and RT300-SP (Model FA100053) are both External Functional Neuromuscular Stimulators, but their specific differences (if any) are not detailed in the regulatory data. Consultation with the manufacturer or a specialist is recommended to ensure the chosen model aligns with the patient’s clinical requirements, as both are intended for neurological conditions like stroke or spinal cord injury.

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 - 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) K060032 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026