(15 days)
Not Found
No
The document describes a traditional muscle stimulation and interferential current stimulation device with fixed parameters and modes of operation. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is described as a muscle stimulator and pain relief device with specific therapeutic indications such as relaxing muscle spasms, preventing disuse atrophy, and relieving pain.
No
The device description indicates that the RS2mi device family provides muscle stimulation and interferential current stimulation modalities for therapeutic purposes such as relaxing muscle spasms, pain relief, and improving circulation, rather than diagnosing conditions.
No
The device description explicitly states that the RS2mi device family consists of a "hardware/software system" and details hardware components like a plastic enclosure, LED indicators, output cables, electrode pads, and an AC Charging Adapter. It also specifies electrical parameters for the stimulation modalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed (muscle stimulation, pain relief) are all related to treating or managing conditions within the human body. IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a device that applies electrical stimulation directly to the patient's body via electrodes. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device described is a therapeutic electrical stimulator.
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 (comma separated list FDA assigned to the subject device)
89 IPF, 84 LIH
Device Description
The RS2mi device family consists of a hardware/software system that can be setup as one of four devices: an RS2m which is a pulse mode muscle stimulator only, an RS2i which is an interferential stimulator only, an RS2c which can act as either a pulse mode muscle stimulator or an interferential stimulator, or an RS2s which acts as a sequential stimulator by first providing an interferential treatment segment followed by a pulse mode muscle stimulation segment. The software system is setup to emulate one of these four devices and the device faceplate is setup to indicate to the user the features of that device only. To provide flexibility, the faceplates can be interchanged by RS Medical to create the type of device needed in the marketplace. Throughout this document the name RS2mi is used to indicate this 'family' of four separate devices.
The RS2mi device family, 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 RS2mi is housed in a plastic enclosure. The front of the enclosure houses LED patient indicators. The accessories provided with the RS2mi include the output cables, the electrode pads, and the AC Charging Adapter.
The RS2mi 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 RS2mi 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
Premarket Notification RS Medical RS2mi (Rev 2)
510(k) SUMMARY RS2mi family May 15, 2002
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, Inc. 14401 SE First St. Vancouver, WA 98684-6981
Attn: Mike McGraw, Vice President, Product Development Telephone: (360) 896-2503 Fax: (306) 896-2566
Submitter of 510(k) and Third Party Reviewer
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: RS2mi 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 RS2mi family is substantially equivalent to its legally marketed predecessor the RS-4M Plus (K000114) muscle stimulator.
1
Premarket Notification RS Medical RS2mi (Rev 2)
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 RS2mi device family consists of a hardware/software system that can be setup as one of four devices: an RS2m which is a pulse mode muscle stimulator only, an RS2i which is an interferential stimulator only, an RS2c which can act as either a pulse mode muscle stimulator or an interferential stimulator, or an RS2s which acts as a sequential stimulator by first providing an interferential treatment segment followed by a pulse mode muscle stimulation segment. The software system is setup to emulate one of these four devices and the device faceplate is setup to indicate to the user the features of that device only. To provide flexibility, the faceplates can be interchanged by RS Medical to create the type of device needed in the marketplace. Throughout this document the name RS2mi is used to indicate this 'family' of four separate devices.
The RS4M+ incorporates all of these features in one unit, the primary difference is that the predicate device has 4 channels, while the RS2mi has only 2 channels
The RS2mi device family, 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 RS2mi is housed in a plastic enclosure. The front of the enclosure houses LED patient indicators. The accessories provided with the RS2mi include the output cables, the electrode pads, and the AC Charging Adapter.
Both the RS4M+ and the RS2mi use the same materials and texture for the enclosure. Only the enclosure color (TBD) is different. The RS4M+ uses a 2-line LCD Patient Indicator Display. The RS2mi uses LEDs. The RS2mi is designed to use the same output cables, electrode pads, and the AC Charging Adapter as the predicate device
2
The RS2mi 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 RS4M+ is the same.
The RS2mi 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).
The RS4M+ is the same.
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized eagle emblem, composed of three profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Mrs. Molly Bettger RS Medical C/O: Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, WA 98607-8542
Re: K021763
Trade/Device Name: RS2mi muscle stimulator family, models: RS2m, RS2i, RS2c, and RS2s Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: 89 IPF and 84 LIH Dated: May 20, 2002 · Received: May 29, 2002
Dear Mrs. Bettger:
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
4
Page 2 - Mrs. Bettger
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stept
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
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Premarket Notification RS Medical RS-2mi
Premarket Notification
Indications For Use
Device Name: RS2mi 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)
(Optional Format 1-2-96)
OR
Over-The-Counter:
Htyk Purdy
(Division Sign-Off) Division of General, Restorative and Neurological Devices
1021763 510(k) Number __
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