NESS SYSTEM

K022776 · Ness-Neuromuscular Electrical Stimulation Systems · IPF · Sep 11, 2002 · Physical Medicine

Device Facts

• Record ID: K022776
• Device Name: NESS SYSTEM
• Applicant: Ness-Neuromuscular Electrical Stimulation Systems
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NESS System is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

Device Story

NESS System is a portable, one-channel, battery-powered neuromuscular electrical stimulator for personal use. Device utilizes surface electrodes held against limbs via specialized splints (hand, forearm, thigh, leg). Microprocessor controls constant-voltage symmetrical biphasic Russian waveform stimulation; stimulation cycles between electrodes to activate muscles; ramped intensity at cycle start/end. User selects from five programs and ten intensity levels via control unit. Intended for home use by patients to improve limb function and muscle health. Output provides limb extension and flexion distal to splint site. Clinical benefit includes improved range of motion and muscle maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Portable, one-channel constant-voltage neuromuscular electrical stimulator. Powered by rechargeable nickel-cadmium batteries. Delivers symmetrical biphasic Russian waveform. Includes four plastic splint configurations for various limb sites. Microprocessor-controlled stimulation switching and intensity adjustment (10 levels).

Indications for Use

Indicated for patients requiring neuromuscular electrical stimulation for maintenance/increase of range of motion, reduction of muscle spasm, prevention/retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

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

• N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster NMS1 (K952273, K982482)

Submission Summary (Full Text)

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K022776
IOPD

### 510(K) SUMMARY

# N.E.S.S. NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS LTD. NESS SYSTEM POWERED MUSCLE STIMULATOR

N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. Applicant: 19 Ha-Haroshet Street Keidar Center Suite 207 P.O. Box 2500 Industrial Zone Ra'anana, 43465

> ISRAEL Tel: [phone] Fax: [phone]

#### Contact Persons:

Orly Maor Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone]

And/or

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone]

NESS System Trade Name:

Common/Usual Name: External Neuromuscular Stimulator

Classification Name: Powered Muscle Stimulator

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K022776
20F2

#### Predicate Device:

N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster NMS1 (K952273, and K982482).

#### Intended Use:

The NESS System is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

#### Device Description:

The NESS System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the thigh, or the leg is provided.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessorcontrolled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.

The electrode locations allow the NESS System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

## Predicate Device & Substantial Equivalence

The NESS System is substantially equivalent to the market-cleared Handmaster NMS1. The only difference between the NESS System and the Handmaster NMS1 is the provision of additional plastic splints to allow the system to treat other sites on the limbs: the upper arm, the thigh, and the lower leg.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2002

Neuromuscular Electrical Stimulation Systems, Ltd. C/O·Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K022776

Trade/Device Name: NESS System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPG Dated: August 21, 2002 Received: August 21, 2002

Dear Mr. Kahan:

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 application (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 such additional controls. Existing major regulations affecting your 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.

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

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Page 2 -- Mr. Jonathan S. Kahan

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 begin 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark A Millman

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

Enclosure

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### ATTACHMENT 7-3.

### INDICATIONS FOR USE STATEMENT

510(k) Number:_

Device Name:

NESS System

### Indications for Use:

The NESS System is intended to be used for the following indications:

- maintenance or increase of range of motion, ●
- reduction of muscle spasm, ●
- prevention or retardation of disuse atrophy, .
- muscle reeducation, and ●
- increasing local blood circulation. .

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR

7-6

Over the Counter Use

for Mark N. Millman
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

\\\PH - 64270/0001 - 10753 v1

510(k) Number .

K022776