(66 days)
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Not Found
No
The provided text describes a muscle stimulator with various waveforms and indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies sections.
Yes
The device is indicated for the treatment of various medical conditions, including muscle spasms, disuse atrophy, and pain, which are conditions addressed by therapeutic devices.
No
Explanation: The device is a muscle stimulator intended for treatment purposes like relaxation of muscle spasms, prevention of disuse atrophy, and pain management. It does not perform any diagnostic functions.
No
The provided text only describes the intended use and indications for a muscle stimulator, which is a hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided text describes a muscle stimulator that uses electrical waveforms to treat various conditions related to muscles and pain. This is a therapeutic device that interacts directly with the body, not a device that analyzes samples taken from the body.
- Intended Use: The listed indications for use (muscle relaxation, preventing atrophy, increasing circulation, pain relief, etc.) are all related to direct treatment of the body, not diagnostic testing of samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:
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- Relaxation of muscle spasms.
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- Prevention or retardation of disuse atrophy.
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- Increasing local blood circulation.
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- Muscle re-education.
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- Maintaining or increasing range of motion.
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- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:
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- Symptomatic relief of chronic intractable pain.
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- Management of pain associated with post-traumatic or post operative conditions.
Product codes
IPF, GZJ, LIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2002
Mr. David Richards Vice President. Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 Inola, Oklahoma 74036-0879
Re: K013770/S1
Trade/Device Name: Winner ST-2 Regulation Numbers: 21 CFR 890.5850 and 21 CFR 882.5890 Regulation Names: Powered Muscle Stimulator and Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Codes: IPF, GZJ and LIH Dated: December 13, 2001 Received: January 7, 2002
Dear Mr. Richards:
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
1
Page 2 - Mr. David Richards
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.
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 legally marketed predicate devices 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) 594-4659. 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 vours.
Mark n Milkenson
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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Page 1 of 1
510(k) Number (if known): K013770
Device Name: Rich-Mar Winner ST-2
Indications For Use:
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:
-
- Relaxation of muscle spasms.
-
- Prevention or retardation of disuse atrophy.
-
- Increasing local blood circulation.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:
-
- Symptomatic relief of chronic intractable pain.
-
- Management of pain associated with post-traumatic or post operative conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkman
of General, Restorative and Neurological Devices
510(k) Number_