ORTHO DX NEUROMUSCULAR STIMULATOR

K971542 · Rehabilicare, Inc. · IPF · Aug 14, 1997 · Physical Medicine

Device Facts

• Record ID: K971542
• Device Name: ORTHO DX NEUROMUSCULAR STIMULATOR
• Applicant: Rehabilicare, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

Device Story

Ortho Dx is a non-invasive, prescription-only neuromuscular stimulator; operates under medical supervision. Device combines symmetrical biphasic neuromuscular stimulation and high volt pulsed direct current; modes function simultaneously or independently. System delivers electrical pulses to patient musculature; intended to relax spasms, retard atrophy, improve circulation, reeducate muscles, prevent venous thrombosis, and increase range of motion. Clinician adjusts parameters including amplitude, pulse width, pulse rate, treatment time, and ramp times. Output affects muscle contraction and physiological response to aid rehabilitation. Device utilizes UL-approved power supply.

Clinical Evidence

Bench testing only. Verification of output waveforms, amplitude, pulse width, pulse rate, treatment time, and ramp times performed at room temperature (72°C) and 50% relative humidity using calibrated measurement equipment. Results confirmed parameters are within or identical to predicate device specifications.

Technological Characteristics

Non-invasive electrical stimulator; symmetrical biphasic and high volt pulsed direct current output modes. Parameters: amplitude, pulse width, pulse rate, treatment time, ramp up/down times. Powered by UL-approved power supply. Operates at room temperature (72°C).

Indications for Use

Indicated for patients undergoing rehabilitation for medical diseases and conditions requiring adjunctive electrical stimulation therapy to relax muscle spasms, prevent/retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis (post-surgical calf stimulation), and increase 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

• GV II Neuromuscular Stimulator, Model 9700/7000S (K881082)
• Neuromuscular II (NMIII), Model 6800S (K840346)
• TRI-STIM Stimulator, Muscle, Electrical Powered (Registration No. not known)

Submission Summary (Full Text)

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# 510(k) Summary

# Ortho D. Neuromuscular Stimulator

K971542

#### Model 6700S

#### Product:

Ortho Dx Neuromuscular Stimulator, Model 6700S

# AUG / 4 097

## Classification:

Class II

#### Manufacture:

Rehabilicare Inc.

· 1811 Old Highway 8 New Brighton, MN 55112 Phone No. [phone]

## Contact:

Gary L. Moore Phone No. [phone]

## Predicate Products:

- GV II ™ Neuromuscular Stimulator, Model 9700/7000S, K881082 -
- Neuromuscular II (NMIII TM), Model 6800S, K840346 -
- TRI-STIM Stimulator, Muscle, Electrical Powered, Registration No. not known -

## Indications For Use:

The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

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#### Device Description:

The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.

#### Summary of Testing:

The output wave form, amplitude, pulse width, pulse rate, treatment time, NMS off time, NMS ramp up time and NMS ramp down time have been verified to the technical requirements listed in the operators manual. All measurements were taken at room temperature (72°C) with a relative humidity of 50% using a calibrated 5V power supply with a maximum capacity of 3 ampere continuous current and calibrated measurement equipment. These values are within and/or identical to the operating parameters of the predicate devices. The Ortho Dx neuromuscular stimulator uses the same power supply and proposes no additional safety considerations than the legally marketed predicate devices (NM II/III and GV II). The Line Powered Repac10 employees a UL approved power supply and is legally marketed with the predicate devices (NM II/II and GV II).

#### Substantial Equivalence Summary:

The Ortho Dx ™ is a neuromuscular stimulator with a symmetric biphasic output wave form identical to the Mentor Neuromuscular II (NM III ™ ), Model 6800S, Neuromuscular Stimulator, Registration Number, K840346, and a high volt pulsed current output wave form identical to the GV II M Model 9700, High Voltage Pulsed Galvanic Stimulator, Registration Number, K881082. This type of unit, combining both types of output wave forms, is similar to a predicate device, the TRI-STIM ™ , Stimulator, Muscle, Electrical Powered, manufactured by Henley, a Division of Maxxim Medical, 104 Industrial Blvd., Sugarland, TX 77478 (registration number unknown).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary L. Moore Director of Engineering Rehabilicare Inc. 1811 Old Hiqhway 8 New Brighton, Minnesota 55112

AUG / 4 1997

Re : K971542 Ortho Dx™ Neuromuscular Stimulator Regulatory Class: II Product Code: IPF Dated: July 29, 1997 Received: August 4, 1997

Dear Mr. Moore:

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, Druq, 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, 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 requlations 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 requlation (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. Gary L. Moore

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510(K) prematice notification: - tho legally Finding of Bubboandar organisation a classification for your markets production permits your device to proceed to the market.

If you desire specific advice for your device on our labeling i regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at [phone]. Also, please note the Office or compriation as (compranding 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,

ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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### Statement for Indication of Use:

The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used - to, relax muscle spasm, prevent or retard disuse … atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

Sign-Off

51.JK, Number

Prescription Use
(Per 21 CFR 801.109)