ELECTROPULSE-COSMETIC

K113724 · Pain Relief Technologies · NFO · Feb 15, 2012 · Neurology

Device Facts

• Record ID: K113724
• Device Name: ELECTROPULSE-COSMETIC
• Applicant: Pain Relief Technologies
• Product Code: NFO · Neurology
• Decision Date: Feb 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use. Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.

Device Story

ElectroPulse-Cosmetic device provides transcutaneous electrical nerve stimulation (TENS) and near-infrared (IR) light/heat therapy. Device operates via electrical stimulation for cosmetic facial purposes and IR emission for muscle relaxation and local blood circulation. Intended for over-the-counter use by consumers. Device applies energy to target tissues; healthcare providers do not operate. Output affects local tissue physiology through electrical stimulation and thermal effects. Benefits include temporary muscle relaxation and improved local circulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device utilizes transcutaneous electrical nerve stimulation (TENS) and near-infrared (IR) light/heat emission. Classified under 21 CFR 882.5890. Regulatory class II. Product codes NFO, ILY.

Indications for Use

Indicated for cosmetic facial stimulation, temporary muscle relaxation, and temporary increase of local blood circulation via near-IR energy. Intended for over-the-counter use.

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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pain Relief Technologies, Inc. c/o Mr. Kendall Gorham President 15048 SW Capstone Court Beaverton, OR 97007

FEB 1 5 2012

Re: K113724

Trade/Device Name: Electropulse - Cosmetic Regulation Number: 21 CFR 882.5890. Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: II Product Codes: NFO, ILY Dated: December 15, 2011 Received: December 19, 2011

Dear Mr. Gorham:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Keria Alexander

Malvina B. Eydelman, M.D.

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Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

k 113724 510(k) Number:

Device Name: ElectroPulse -- Cosmetic

Indications For Use:

TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.

Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k113724

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