NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM

K973929 · Neotonus, Inc. · IPF · May 21, 1998 · Physical Medicine

Device Facts

• Record ID: K973929
• Device Name: NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
• Applicant: Neotonus, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: May 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Story

System comprises stimulator control unit and treatment wand; wand contains 'C'-shaped magnetic coil. Control unit generates voltage signal to charge coil; coil held against patient skin over target muscle group. User-adjustable parameters: pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle (1-30 sec), off-cycle (0-60 sec). Used under medical supervision for rehabilitative muscle excitation. Magnetic stimulation induces neuromuscular tissue response; produces muscle contractions comparable to electrical stimulation. Benefits include muscle re-education, spasm reduction, and atrophy prevention.

Clinical Evidence

Clinical study with nine healthy volunteers. Compared MS-101 magnetic stimulation to RICH-MAR electrical stimulation on knee extensor muscles. Results showed comparable skeletal muscle responses, identical sigmoidal relationships between stimulus amplitude/frequency and muscle torque, and similar muscle fatigue and relaxation time profiles.

Technological Characteristics

Magnetic muscle stimulator; consists of control unit and 'C'-shaped magnetic coil wand. Energy source: electrical pulse generator. Adjustable parameters: frequency (1-55 Hz), amplitude (0-100%), duty cycle (1-30s), rest period (0-60s). Non-invasive, external application.

Indications for Use

Indicated for patients requiring neuromuscular stimulation for rehabilitative purposes, including relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, prevention of venous thrombosis via calf muscle stimulation, and maintaining/increasing range of motion in legs or arms.

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

• RICH-MAR Theratouch electrical muscle stimulator

Submission Summary (Full Text)

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## 510(k) Summary

# Neotonus, Inc. MS-101 Magnetic Muscle Stimulator System

K973929

- Sponsor 1.
Neotonus, Inc. 810-A Franklin Court Marietta, GA 30067

Tony J. Morris Contact Person: President

May 21, 1998 Date Prepared:

### Devicc Name 2.

Classification Name: Powered Muscle Stimulator, 21 CFR 890.5850, Product Code 89IPF, Class II MS-101 Magnetic Muscle Stimulator System Proprietary Name:

#### Intended Use 3.

The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

- Relaxation of muscle spasms 8
- Prevention or retardation of disuse atrophy 4
- Increasing local blood circulation .
- Muscle re-education .
- Immediate post-surgical stimulation of call muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion .

#### 4. Device Description

The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that

and the comments of the management one offer and the county of the market of the many

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periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).

#### Basis For Substantial Equivalence ર્ડ

The MS-101 is substantially equivalent to electrical stimulators used for muscle renabilitation and the indications as stated above. In particular, the MS-101 is substantially equivalent to the RICII-MAR Theratouch electrical muscle stimulator. A clinical study was conducted to compare the physiological effect of the MS-101 to that of the RICH-MAR electrical stimulator. The knee extensor muscles of nine healthy volunteers with varying degrees of muscle tone were stimulated using both the MS-101 and the electrical muscle stimulator. The study showed that:

- . The skelctal muscle responses evoked by the MS-101 were comparable to those evoked using the RICH-MAR electrical stimulator.
- . Both types of stimulation evoked the classic sigmoidal relationships between stimulus amplitude and muscle torque and between stimulus frequency and muscle torque.
- Both types of stimulation evoked the classic muscle fatigue and increased one-. half relaxation time with repeat contractions.
- The MS-101 is substantially equivalent to electromyostimulation for muscle rehabilitation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 1998

Mr. James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. Representing Neotonus, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K973929 Neotonus MS-101 Magnetic Muscle Stimulator System Regulatory Class: II Product Code: IPF Dated: February 18, 1998 Received: February 20, 1998

Dear Mr. Veale:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Frid and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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### Page 2 - Mr. James R. Veale

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 requlation (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 gener 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,

Jacotte

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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## 510(k) Number (it known): K973929

## Device Name: NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM

### Indications For Use:

The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in sumulating neuromuscular tiasucs for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Usc for Muscle Stimulators:

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy t
- Increasing local blood circulation レ
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANCITITUR PAGE 16 NECESSARY

Concurrence of CDRH, Office of Donco Evaluation (ODE)

Prescription Use (Fer 21 CFR 801.109

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Robert J. De Luca