ULTRA-GARMENT ELECTRODE

K993130 · Newwave Medical, LLC · GXY · Dec 17, 1999 · Neurology

Device Facts

• Record ID: K993130
• Device Name: ULTRA-GARMENT ELECTRODE
• Applicant: Newwave Medical, LLC
• Product Code: GXY · Neurology
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "Ultra Garment Electrode" is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.

Device Story

Ultra Garment Electrode is a reusable, stretchable, electrically conductive garment (glove, sock, or sleeve). Device functions as an interface between a patient and legally marketed electrical stimulation units (TENS, HVPG, or INF). Physician prescribes device for clinical or home use where electrical stimulation therapy is indicated. Garment delivers electrical current to the skin surface to facilitate nerve or muscle stimulation. Benefits include providing a conductive medium for therapeutic electrical stimulation.

Clinical Evidence

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

Technological Characteristics

Stretchable, electrically conductive textile garment (glove, sock, or sleeve). Reusable. Functions as a cutaneous electrode for TENS, HVPG, and INF stimulation units.

Indications for Use

Indicated for use with legally marketed transcutaneous electrical nerve stimulators (TENS), high volt pulsed galvanic stimulators (HVPG), and interferential (INF) units. Prescription use only.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• SMD Electrodes (K943009)
• Electro-Mesh Glove Electrodes Prizm Medical (K932299)

Submission Summary (Full Text)

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

DEC 1 7 1999

## Attachment A

## 510(k) Summary of Safety and Effectiveness

| Date Prepared: | September 15, 1999 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Newwave Medical, LLC<br>1538 Haven Place<br>Allen , TX 75002<br>[phone] |
| Contact Person: | Robert Armstrong |
| Trade (Proprietary) Name: | Ultra Garment Electrode |
| Common/Classification Name: | Cutaneous Electrode |
| Device Classification: | Class II |
| Predicate Devices: | SMD Electrodes (k943009)<br>Electro-Mesh Glove Electrodes<br>Prizm Medical (K932299) |
| Description of the Device | The Ultra Garment Electrode is a Stretchable<br>Electrically Conductive glove, sock, or sleeve,<br>Reusable. |
| Statement of Intended Use: | The "Ultra Garment Electrode" is intended to be<br>used as an electrically conducting garment to be<br>prescribed for usage by a physician for use where<br>an electrode is appropriate. |
| Technological Characteristics: | The new device has the same technological<br>characteristics as the predicate devices. See<br>Table 1 (next page) for a summary of the new<br>device in comparison to those of the predicate<br>devices. |

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1999

Robert Armstrong Newwave Medical LLC. 1538 Haven Place Allen, TX 75002

Re: K993130 Trade Name: Ultra-Garment Electrodes Regulatory Class: II Product Code: GXY Dated: September 15, 1999 Received: September 20, 1999

Dear Mr. Armstrong:

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 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 (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. 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 regulation (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.

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

## Page 2 - Robert Armstrong

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 regulation (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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Neil RP Ogden for
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page

: ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

S10(k) NUMBER (IF KNOWN): K993130

DEVICE NAME: ULTRA-GARMENT

INDICATIONS POR USE:

RDTSCAN

## ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.

NRo for

(Division Sign-Off) Division of General Restorative Devices K993130 510(k) Number .

(FLASSE DO NOT WRITE BRICH THIS LINE-CONTINUE ON ANOTH IF NEBOBD.)

Concurrence of CORK, Office of Device Braluation (

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Coun (Optional F