(27 days)
K84223
Not Found
No
The summary describes a simple muscle stimulator with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as being used to relieve symptoms, treat dysfunction and pain, relax muscles, increase local blood circulation, and increase or maintain range of motion, all of which are therapeutic actions.
No
The device description and intended use indicate it is a therapeutic device (muscle stimulator) designed to relieve symptoms and relax muscles, not to diagnose conditions.
No
The device description explicitly states it is a "battery operated muscle stimulator," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a muscle stimulator that is applied externally to the head and neck to treat symptoms and conditions. It does not analyze any biological samples.
The intended use and device description clearly indicate a therapeutic device used for physical stimulation, not for in vitro analysis of biological specimens.
N/A
Intended Use / Indications for Use
Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.
Product codes
NUW
Device Description
The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2005
Mr. Fray Adib President Myotronics-Noromed. Incorporated 15425 53td Ave South Tukwila, Washington 98188
Re: K031998
Trade/Device Name: Model J-5 Myo-Monitor Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NUW Dated: June 24,2003 Received: July 8,2003
Dear Mr. Adib:
This letter corrects our substantially equivalent letter of July 24.2003. regarding the classification of your device which was incorrectly identified as "unclassified."
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 (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 additional controls. Existing major regulations affecting you 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.
1
Page 2 - Mr. Fray Adib
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.
This letter will allow you to continue 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 (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
JUL 2 4 2003
Special 510(k) Myotronics-Noromed, Inc
510(k) SUMMARY
Model J-5 Myo-monitor
510(k) # K031998
June 24, 2003
Myotronics-Noromed, Inc. 15425 – 53td Avenue South Tukwila, WA 98188 Telephone (206) 243-4214 Contact: Mr. Fray Adib, President
. Fray Adib, President
Device: Model J-5 Myo-monitor
Legally marketed predicate device: Model J-4 Myo-monitor (K842223) Myotronics-Noromed. Inc.
Description of the Device: The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.
Intended Use: Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.
Comparison with predicate device: The Model J-5 Myo-monitor has exactly the same intended uses and fundamental technology as its predecessor, the Model J-4 Myomonitor. The design change which is the subject of this premarket notification is to add an additional pair of stimulating channels with separate controls. This permits treatment of four muscle sites simultaneously as opposed to the two muscle site capability of the predecessor device.
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K031998 510(k) Number (if known):
Model J-5 Myo-monitor Device Name:
INDICATIONS FOR USE
- 公 To treat Temporomandibular Joint (TMJ) dysfunction and associated pain
-
To relieve symptoms associated with muscle spasm
- To relax muscles and establish a physiologic occlusion A
-
To take occlusal registrations
-
To take denture impressions
-
To increase local blood circulation
-
To maintain or increase mandibular range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mh. Udh for MSR
hesiology. General Hospital,
510(k) Number. K031498
Prescription Use_ XX (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________