RS-4V MUSCLE STIMULATOR

• K Number: K990697
• Device Name: RS-4V MUSCLE STIMULATOR
• Manufacturer: RS MEDICAL
• Date Cleared: 1999-06-18 ( 107 days)
• Product Code: IPF
• Regulation Number: 890.5850

Intended Use

Muscle Stimulator Modality - Relax muscle spasms - Prevent or retard disuse atrophy - Maintain or increase range of motion - Increase local blood circulation - Re-educate muscle - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Interferential Current Modality - Relieve acute pain - Relieve and manage chronic pain - Relax muscle spasms - Maintain or increase range of motion - Increase local blood circulation

Device Description

The RS-4V, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4V is housed in a plastic enclosure. The front of the enclosure houses LCD operator display. The accessories provided with the RS-4 V include the output cables, the electrode pads, and the AC Charging Adapter. The RS-4V muscle stimulation modality operates at approximately 100 volts peak (no load) and 60 mA peak (1000 ohm load) with a pulse width of 415 uSec.(maximum) and a cycle frequency of 71 Hz. The pulses are bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting. The RS-4V interferential modality operates at approximately 100 mA peak-to-peak on a 500 ohm load. The carrier and interferential signals are true sine wave symmetric outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

Predicate Devices

K953136, K973223

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional electrical stimulation modalities and their parameters, with no mention of AI or ML.

Therapeutic

Yes
The device is described as a muscle stimulator and interferential current stimulator, with indications for use that include therapeutic benefits such as relaxing muscle spasms, relieving pain, preventing disuse atrophy, and increasing range of motion.

Diagnostic

No

The device description and intended use/indications for use describe the device as a stimulator for therapeutic purposes related to pain relief, muscle relaxation, and improved circulation, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is housed in a plastic enclosure and includes accessories such as output cables, electrode pads, and an AC Charging Adapter, indicating it is a hardware device with associated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The listed uses are all related to physical therapy and pain management through electrical stimulation applied to the body. This is a direct interaction with the patient's body, not the examination of specimens derived from the human body.
• Device Description: The description details an electrical stimulator with electrodes and cables, designed to deliver electrical currents to the patient. This aligns with the function of a physical therapy device, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

In summary, the RS-4V is a therapeutic device used for muscle stimulation and pain relief, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• Relax muscle spasms .
• Prevent or retard disuse atrophy ●
• Maintain or increase range of motion .
• Increase local blood circulation .
• . Re-educate muscle
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .
• Relieve acute pain ●
• Relieve and manage chronic pain .
• Relax muscle spasms .
• Maintain or increase range of motion ●
• Increase local blood circulation .

Product codes

IPF

Device Description

The RS-4V, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4V is housed in a plastic enclosure. The front of the enclosure houses LCD operator display. The accessories provided with the RS-4 V include the output cables, the electrode pads, and the AC Charging Adapter.

The RS-4V muscle stimulation modality operates at approximately 100 volts peak (no load) and 60 mA peak (1000 ohm load) with a pulse width of 415 uSec.(maximum) and a cycle frequency of 71 Hz. The pulses are bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.

The RS-4V interferential modality operates at approximately 100 mA peak-to-peak on a 500 ohm load. The carrier and interferential signals are true sine wave symmetric outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K953136, K973223

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

0

K990697

510(k) SUMMARY RS-4V February 28, 1999

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87.

1. Applicant. Official Correspondent and Owner of 510(k)

RS Medical P.O. Box 4656 Vancouver. WA 98662-0656

Attn: Mike McGraw, Vice President, Research and Development [phone] Telephone: Fax: [phone]

Submitter of 510(k) and Consultants

Joel S. Faden, Ph.D., Inc. 11605 Hitching Post Lane Rockville, MD 20852 [phone] Telephone: Fax: [phone]

2. Name of Device

Trade/Proprietary Name: RS-4V Muscle Stimulator

Common/Usual Name: Muscle and Interferential Current Stimulator

Classification Name: 21 CFR 890.5850 "Powered Muscle Stimulator", Class 11.

3. Legally Market Predicate Devices

The RS-4V is substantially equivalent to its legally marketed predecessor the RS-4M (K953136) muscle stimulator and Stellar HS-04 (K973223) muscle stimulator.

Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to refer to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation. Preamble. August 23. 1977. FR 42520 (Docket No. 76N-0355))

1

Premarket Notification RS Medical RS-4V

4. Indications for Use

Muscle Stimulator Modality

• Relax muscle spasms .
• Prevent or retard disuse atrophy ●
• Maintain or increase range of motion .
• Increase local blood circulation .
• . Re-educate muscle
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Current Modality

• Relieve acute pain ●
• Relieve and manage chronic pain .
• Relax muscle spasms .
• Maintain or increase range of motion ●
• Increase local blood circulation .

5. Device Description and Substantial Equivalence

The RS-4V, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4V is housed in a plastic enclosure. The front of the enclosure houses LCD operator display. The accessories provided with the RS-4 V include the output cables, the electrode pads, and the AC Charging Adapter.

The RS-4V muscle stimulation modality operates at approximately 100 volts peak (no load) and 60 mA peak (1000 ohm load) with a pulse width of 415 uSec.(maximum) and a cycle frequency of 71 Hz. The pulses are bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.

The RS-4V interferential modality operates at approximately 100 mA peak-to-peak on a 500 ohm load. The carrier and interferential signals are true sine wave symmetric outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1999

Mr. Mike McGraw Vice President, Research and Development RS Medical Corporation P.O. Box 4656 98662-0656 Vancouver, Washington

K990697 Re: RS-4V Muscle Stimulator Trade Name: Requlatory Class: II Product Code: IPF June 1, 1999 Dated: Received: June 2, 1999

Dear Mr. McGraw:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

3

Page 2 - Mr. Mike McGraw

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Premarket Notification RS Medical RS-4V

Indications For Use

Device Name: RS-4V Muscle Stimulator

Indications For Use:

Muscle Stimulator Modality

• Relax muscle spasms ●
• Prevent or retard disuse atrophy ●
• Maintain or increase range of motion ●
• Increase local blood circulation .
• Re-educate muscle .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis ●

Interferential Current Modality

• . Relieve acute pain
• Relieve and manage chronic pain ●
• Relax muscle spasms ●
• Maintain or increase range of motion ●
• Increase local blood circulation ●

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

X OR

Over-The-Counter:

bata

(Optional Format 1-2-96)