COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH

K013507 · Cosmo Health, Inc. · GZJ · Jan 25, 2002 · Neurology

Device Facts

• Record ID: K013507
• Device Name: COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
• Applicant: Cosmo Health, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.

Device Story

The COSMO TENS PF-990 is a digital wireless transcutaneous electrical nerve stimulator (TENS). The device is a patch-based unit applied directly to the skin. It delivers low-frequency electrical currents to stimulate nerve pathways for pain management. It is intended for the symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain. The device is operated by the patient or clinician; it must be securely attached to the skin prior to activation. The electrical stimulation provides therapeutic benefit by targeting nerve pathways to alleviate pain symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital wireless transcutaneous electrical nerve stimulator (TENS). Operates via low-frequency electrical current delivery. Form factor is a wearable patch. Class II device under 21 CFR 882.5890.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic pain, 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

## JAN 2 5 2002

COSMO Health, Inc. C/O Jean-Claude Amar Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K013507/S1

Trade/Device Name: COSMO TENS PF-990 Mini Digital Wireless Patch Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: December 27, 2001 Received: December 28, 2001

Dear Mr. Amar:

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. Jean-Claude Amar

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,

R. Mark N. Millerson

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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COSMO HEALTH. INC., NE COSMO TENS P

KOIBSTI

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Device Name:

K013507 COSMO TENS PF-990.

Indications for Use:

The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;"> ✓ </div> |
|------------------|--------------------------------------------------------------------------|
| | OR |
| | Over-The-Counter Use _______ |

(Per 21 CFER 801.109) and (Optional Format 1-2-96)

for Mark N. Melkers

(Division Sign-Off Division of General Restorative and Neurological Devices

| 510(k) Number | K013507 |
|---------------|---------|
|---------------|---------|

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ