PANAG

K011891 · Panag International · GZJ · Jul 30, 2002 · Neurology

Device Facts

• Record ID: K011891
• Device Name: PANAG
• Applicant: Panag International
• Product Code: GZJ · Neurology
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The "Panag" is a battery operated portable transcutaneous electrical nerve stimulator used to apply an electrical current through electrodes to a patient's skin for symptomatic pain relief. For the symptomatic relief of chronic intractable, post-traumatic and post-surgical pain.

Device Story

Panag is a battery-operated, portable transcutaneous electrical nerve stimulator (TENS). Device applies electrical current to patient skin via electrodes. Used for symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain. Operated by patient or clinician. Output is electrical stimulation to nerves; intended to modulate pain perception. Device provides non-invasive pain management alternative.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use for TENS devices.

Technological Characteristics

Battery-operated portable transcutaneous electrical nerve stimulator. Delivers electrical current via skin electrodes. Class II device (Product Code GZJ).

Indications for Use

Indicated for symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain in patients requiring transcutaneous electrical nerve stimulation.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 3 0 2002

Mr. Peter Kalabakas Panag International 43 Derby Road Bertrams Johannesburg South Africa 2094

Re: K011891 Trade/Device Name: Panag Regulation Number: 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: May 27, 2002 Received: June 10, 2002

Dear Mr. Kalabakas:

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 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.

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Page 2 - Mr. Peter Kalabakas

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 vours.

- Mark A. Millhuser

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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## INDICATION FOR USE STATEMENT

K 011891 510(k) Number (if known):

Panag

Device Name:

Indication for Use:

The "Panag" is a battery operated portable transcutaneous electrical nerve stimulator used to apply an electrical current through electrodes to a patient's skin for symptomatic pain relief.

For the symptomatic relief of chronic intractable, post-traumatic and post-surgical pain.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Division Sign-Off

and Neurological Devices

OR

Over-The-Counter Use

ﺔ ﺑﺎﺳ

(Optional Format 1-2-96)

2-2

:

510(k) Number -

Division of General. Restorative