NORODYN 8000 SEMG SYSTEM, ND-8000

K992439 · Myotronics-Noromed, Inc. · HCC · Aug 13, 1999 · Neurology

Device Facts

• Record ID: K992439
• Device Name: NORODYN 8000 SEMG SYSTEM, ND-8000
• Applicant: Myotronics-Noromed, Inc.
• Product Code: HCC · Neurology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For evaluation of the status of muscles at rest and in function . As an aid in muscle re-education and muscle relaxation therapy . Provides ability to compare new captured data with past data to assess progress in treating . patient's relaxation state

Device Story

Norodyn 8000 is a surface electromyographic (SEMG) system measuring electrical potential from muscles. It captures SEMG signals and processes them using Fast Fourier Transformation (FFT) to analyze frequency components. Used in clinical settings by healthcare providers to evaluate muscle status, assist in muscle re-education, and facilitate relaxation therapy. The system allows comparison of current captured data against historical patient data to track treatment progress. Output is provided to the clinician to inform muscle therapy decisions and assess patient relaxation states.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surface electromyographic (SEMG) system. Features software-based Fast Fourier Transformation (FFT) for signal analysis. Operates as a diagnostic and biofeedback tool for muscle evaluation.

Indications for Use

Indicated for patients requiring muscle evaluation, re-education, or relaxation therapy. Used to assess muscle status at rest and during function, and to monitor progress in relaxation therapy.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• ProComp DSP (Thought Technology, Inc.)
• ProComp (Thought Technology, Inc.)
• Myosystem 1000 Electromyograph (Noraxon)
• I-330 Physiological Monitor (J & J Engineering)

Submission Summary (Full Text)

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AUG 13 1999

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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years

Attachment 4

510 (k) SUMMARY

K 99243
<6022270

- 1. Submitter's Information
Date of Submission: July 20, 1999 Name & Address: Myotronics-Noromed, Inc 15425 - 53rd Ave., S. Tukwila, WA 98188 Tel: [phone] Fax: [phone]

Contact Name: Mr. Fray Adib

- Norodyn : 8000 SEMG System 2. Device Trade Name: Common Name: Surface EMG System Device, Biofeedback Classification Name:
- 3. Myotronics-Noromed's intended addition of Fast Fourier Transformation (FFT) of data to the Norodyn 8000 software is substantially equivalent to that feature found in:

ProComp DSP & ProComp mfd. by Thought Technology, Inc. Myosystem 1000 Electromyograph mfd. by Noraxon I-330 Physiological Monitor mfd. by J & J Engineering

- 4. Description of the Device:
The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle.

- 5. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described in the Special 510(k).
Image /page/0/Picture/15 description: The image shows two logos. The first logo on the left has the text "CERTIFIED ISO 9001" on top of the logo. The logo itself has the text "INTERTEK" on top of a globe. The second logo on the right has the text "Accredited by the Council for Accreditation (RvA)" below the logo. The logo itself has a triangle inside of a circle.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:3 1999

Mr. Fray Adib President Myotronics - Noromed, Inc. 15425 53rd Avenue South Tukwila, Washington 98188

Re: K992439

> Trade Name: Norodyn 8000 SEMG System Regulatory Class: II Product Code: HCC Dated: July 20, 1999 Received: July 22, 1999

Dear Mr. Adib:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Fray Adib

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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99-2439 510(k) Number (if known): _ Δ

Norodyn 8000 SEMG System Device Name: _

## Indications for use

. .
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- For evaluation of the status of muscles at rest and in function .
- As an aid in muscle re-education and muscle relaxation therapy .
- Provides ability to compare new captured data with past data to assess progress in treating . patient's relaxation state

## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dccella Ja

eneral Restorative Devices

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use