(15 days)
Not Found
No
The description details traditional electrical stimulation modalities and hardware specifications, with no mention of AI or ML algorithms for data analysis, pattern recognition, or adaptive control.
Yes
The device's intended uses, such as "Relieve muscle spasms," "Prevent or retard disuse atrophy," "Increase local blood circulation," and "Relieve acute pain," clearly indicate that it is designed to treat various medical conditions, thus classifying it as a therapeutic device.
No
The device description and intended use indicate that the RS-4i is a therapeutic device for muscle stimulation and pain relief, not a diagnostic device. It provides electrical stimulation rather than assessing or identifying a condition.
No
The device description explicitly states that the RS-4i device family consists of a "hardware/software system" and describes physical components like a plastic enclosure, LCD display, keypad, output cables, electrode pads, and an AC Charging Adapter. It also details electrical specifications for the muscle stimulation and interferential modalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to muscle stimulation and pain relief through electrical currents applied to the body. These are therapeutic applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details a device that delivers electrical pulses and interferential currents for therapeutic purposes. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Muscle Stimulation, Interferential and Non-Interferential 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 .
Pain Relief, Interferential Current Modality
- Relieve acute pain
- Relieve and manage chronic pain .
Product codes
IPF, LIH
Device Description
The RS-4i device family consists of a hardware/software system that is identical to its predicate device (the RS-4M+ device family K100114). The RS-4i device family manufacturing process has been changed to a Surface Mount process and components. The RS-4i device family includes a 'Pattern Stimulation' modality that allows sequential 'pattern' output of the standard muscle stimulation pulses.
The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Ko 32652 1/2
Premarket Notification RS Medical RS-4i
SEP 1 2 2003
510(k) SUMMARY RS-4i family July 15, 2003
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 14401 SE First St. Vancouver, WA 98684
Attn: Mike McGraw, Vice President, Product Development Telephone: (360) 896-2503 Fax: (306) 896-2566
Submitter of 510(k) and Consultants
Underwriters Laboratories Inc. 2600 NW Lake Road Camas, WA 98607-8542 Telephone: (360) 817-5515 Fax: (360) 817-6133
2. Name of Device
Trade/Proprietary Name: RS-4i Muscle Stimulator family
Common/Usual Name: Muscle and Interferential Current Stimulator
Classification Name: 21 CFR 890.5850 "Powered Muscle Stimulator", Class II.
3. Legally Market Predicate Devices
The RS-4i family is substantially equivalent to its legally marketed predecessor the RS-4M+ (K000114) muscle stimulator.
1
KO32652
2/2
Premarket Notification RS Medical RS-4!
4. Indications for Use
Muscle Stimulation, Interferential and Non-Interferential 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 .
Pain Relief, Interferential Current Modality
- Relieve acute pain ●
- Relieve and manage chronic pain .
5. Device Description and Substantial Equivalence
The RS-4i device family consists of a hardware/software system that is identical to its predicate device (the RS-4M+ device family K100114). The RS-4i device family manufacturing process has been changed to a Surface Mount process and components. The RS-4i device family includes a 'Pattern Stimulation' modality that allows sequential 'pattern' output of the standard muscle stimulation pulses.
The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.
Public Health Service
SEP 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RS Medical c/o Mr. Marc M. Mouser Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607
Re: K032652
Trade/Device Name: RS-4i Muscle Stimulator family Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH Dated: August 21, 2003 Received: August 28, 2003
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Marc M. Mouser
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
ar Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification RS Medical RS-4i
Premarket Notification
Indications For Use
Device Name: RS-4i Muscle Stimulator family
Indications For Use:
Muscle Stimulation, Interferential and Non-Interferential 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
Pain Relief, Interferential Current Modality
- Relieve acute pain ●
- . Relieve and manage chronic pain
(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)
OR
Over-The-Counter:
(Optional Format 1-2-96)
Miriam L. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K632652
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