NEOGENESYS 2K

K022433 · Sanexas Intl. GmbH · LIH · Jan 24, 2003 · Neurology

Device Facts

• Record ID: K022433
• Device Name: NEOGENESYS 2K
• Applicant: Sanexas Intl. GmbH
• Product Code: LIH · Neurology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

PAIN MANAGEMENT Indications for Electromedical Treatment 1. For adjunctive treatment of post-traumatic pain syndromes. 2. For management and symptomatic relief of chronic (long-term) intractable pain. 3. As an adjunctive treatment in the management of post-surgical pain problems. MUSCLE STIMULATION Indications for Electromedical Treatment 1. Relaxation of muscle spasms. 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle reeducation 5. Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis. 6. Maintaining or increasing range of motion Powered Muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Device Story

NEO GeneSys 2k is an electrical signal generator for peripheral nerve stimulation and muscle therapy. Device applies sinusoidal current via two pairs of contact electrodes using temporal interference patterns; alternatively, it can operate using one pair of electrodes. Used in clinical settings under medical supervision for pain relief and adjunctive physical therapy. Output provides therapeutic electrical stimulation to target tissues. Benefits include pain management, muscle spasm reduction, and improved circulation/range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics.

Technological Characteristics

Electrical signal generator; applies sinusoidal current via contact electrodes; utilizes temporal interference patterns; supports dual-pair or single-pair electrode configurations. Class II powered muscle stimulator.

Indications for Use

Indicated for patients requiring pain management for post-traumatic, chronic intractable, or post-surgical pain, and for muscle stimulation to relax spasms, prevent disuse atrophy, increase local blood circulation, reeducate muscles, prevent post-surgical phlebothrombosis, and maintain/increase range of motion. Use restricted to medical supervision.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• ProElecDT (K930263)

Submission Summary (Full Text)

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## 510 (k) Summary

K022433

- Trade name NEO GeneSys 2k .
- . Classification name - Interferential Current Therapy device, Product Code LIH (Unclassified), IPF, GZJ

The legally marketed device to which our firm is claiming equivalence is the ProElecDT, K930263. [807.92(a)(3)].

## Description and Intended Use [807.92(a)(4)] and {807.92(a)(5)]

This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.

# Summary of the technological characteristics [807.92(a) (6)]

There is no difference in technological characteristics between this device and the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

Sanexas International GmbH C/o Mr. Gene Kelly Regulatory/Clinical Consultants, Inc. 200 NE Mulberry, Suite 200 Lee's Summit, MO 64086

Re: K022433

Trade/Device Name: NEO GeneSys 2k Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH, GZJ Dated: October 31, 2002 Received: November 1, 2002

Dear Mr. Kelly:

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. Kelly

forth in the quality systems (OS) 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

L. Mark N. Millers

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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K022433

#### Indications for Use

## NEO GeneSys 2k

## PAIN MANAGEMENT

## Indications for Electromedical Treatment

- 1. For adjunctive treatment of post-traumatic pain syndromes.
- 2. For management and symptomatic relief of chronic (long-term) intractable pain.
- 3. As an adjunctive treatment in the management of post-surgical pain problems.

#### MUSCLE STIMULATION

#### Indications for Electromedical Treatment

- 1. Relaxation of muscle spasms.
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle reeducation
- 5. Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis.
- 6. Maintaining or increasing range of motion

Powered Muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Mark N. Milkerson

:10(k) Number