NESS CHILDREN SYSTEM

K024279 · Ness-Neuromuscular Electrical Stimulation Systems · IPG · Feb 5, 2003 · Physical Medicine

Device Facts

• Record ID: K024279
• Device Name: NESS CHILDREN SYSTEM
• Applicant: Ness-Neuromuscular Electrical Stimulation Systems
• Product Code: IPG · Physical Medicine
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3025
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The NESS Children System is intended for pediatric use 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

Portable, one-channel electrical neuromuscular stimulator for personal pediatric use. Device delivers constant-voltage symmetrical biphasic Russian waveform stimulation via surface electrodes held by limb-specific splints (hand/forearm, arm, thigh, leg). Microprocessor controls stimulation switching between electrodes for cyclic or continuous muscle activation; stimulation intensity ramped at cycle start/end. User selects from five programs and ten intensity levels via control unit. Used for muscle reeducation and atrophy prevention; helps maintain range of motion and blood circulation. Operated by patient or caregiver.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, one-channel neuromuscular stimulator. Powered by rechargeable nickel-cadmium batteries. Delivers constant-voltage symmetrical biphasic Russian waveform. Includes four types of splints in three sizes each for pediatric fit. Microprocessor-controlled stimulation switching and intensity adjustment (10 levels).

Indications for Use

Indicated for pediatric patients 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 prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

Predicate Devices

• Ness System (K022776)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(K) Summary NESS Children System 510(k) Number K 024279

# Applicant's Name:

N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Kiedar Center, Suite 207 P.O. Box 2500, Industrial Zone Ra'anana 43465 ISRAEL Tel: [phone] Fax: [phone]

## Contact Person:

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

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]

## Date Prepared:

December, 2002

{1}------------------------------------------------

## Trade Name:

NESS Children System

## Classification Name:

Powered Muscle Stimulators

## Classification:

The FDA has classified Powered muscle stimulators devices as class II devices (product code 89 IPF, Regulation No. 890.5850) and they are reviewed by the Restorative Devices Branch .

#### Predicate Device:

Ness System cleared under K022776

### Performance Standards:

No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply.

#### Indications:

The NESS Children System is intended for pediatric use 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 Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries,

{2}------------------------------------------------

serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled 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 Children 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.

#### Substantial Equivalence:

NESS Ltd. believes that the NESS Children System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract representation of a human form or bird-like figure, composed of three curved lines.

FEB 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K024279

Trade/Device Name: NESS Children System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPG Dated: December 23, 2002 Received: December 23, 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

{4}------------------------------------------------

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 M 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

{5}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ness Children System

Indications for Use: The NESS Children System is intended for pediatric use 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)

fo *Mark N Milheras*

510(k) Number ***_***__ (Division Sign-Off)

Division of General, Restorative
and Neurological Devices

\$10(k) Number. K024279

Prescription Use ***_*** **OR Over the Counter
(Per 21 CFR 801.109) Use** **_**