MODEL J-5 MVO-MONITOR

K031998 · Myotronics-Noromed, Inc. · NUW · Jul 24, 2003 · Physical Medicine

Device Facts

• Record ID: K031998
• Device Name: MODEL J-5 MVO-MONITOR
• Applicant: Myotronics-Noromed, Inc.
• Product Code: NUW · Physical Medicine
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Model J-5 Myo-monitor is an ultra-low frequency, battery-operated muscle stimulator. It delivers electrical stimulation to head and neck muscles to induce relaxation. The device features four stimulating channels with independent controls, allowing simultaneous stimulation of four muscle sites. It is used by clinicians in a professional setting to facilitate TMJ dysfunction treatment, occlusal registration, and denture impression procedures. By relaxing muscles and increasing local blood circulation, the device assists in establishing physiologic occlusion and improving mandibular range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and intended use.

Technological Characteristics

Ultra-low frequency, battery-operated muscle stimulator. Features four independent stimulating channels. Form factor is a portable electronic unit. No software or complex algorithms described.

Indications for Use

Indicated for patients requiring treatment for TMJ dysfunction and associated pain, muscle spasm relief, muscle relaxation for physiologic occlusion, occlusal registration, denture impression taking, increased local blood circulation, and maintenance or increase of mandibular range of motion.

Regulatory Classification

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.

Predicate Devices

• Model J-4 Myo-monitor (K842223)

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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 [phone] 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

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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 _________________________________________________________________________________________________________________________________________________________