RS-4I Muscle Stimulator Family

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062325

Identifiers

510(k) Number: K062325 FDA 510(k)
FDA Product Code: NYN 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 Rs-4i Muscle Stimulator Family is a powered muscle and interferential current stimulator designed to deliver electrical pulses to patients. It features a plastic enclosure equipped with an LCD display and a keypad for operator control.

This device provides muscle stimulation using bi-phasic pulses and interferential current stimulation. It is authorized under FDA 510k clearance K062325.

Frequently asked questions

What is the primary function of the Rs-4i Muscle Stimulator?

The Rs-4i Muscle Stimulator is designed to deliver electrical pulses to patients. It provides both muscle stimulation using bi-phasic pulses and interferential current stimulation.

How is the device operated?

The device is housed in a plastic enclosure and features an integrated LCD display and a keypad, which allow the operator to control the stimulation settings.

What is the regulatory status of this device?

The Rs-4i Muscle Stimulator Family has received FDA 510k clearance under the number K062325, which indicates it has been found substantially equivalent to legally marketed predicate devices.

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: RS-4i® Plus Sequential Stimulator with Intersperse - RS Medical, RS Medical | Relieve Pain and Restore Function, RS-4I MUSCLE STIMULATOR FAMILY (K032652) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K062325	Class II	Active

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Manufacturer

Manufacturer: Rs Medical

Sources (1)

FDA 510(k) K062325 24 fields · synced Sep 26, 2026