ELECTROPULSE - LOW BACK PAIN

K062532 · Pain Relief Technologies · NUH · Feb 9, 2007 · Neurology

Device Facts

• Record ID: K062532
• Device Name: ELECTROPULSE - LOW BACK PAIN
• Applicant: Pain Relief Technologies
• Product Code: NUH · Neurology
• Decision Date: Feb 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise, or normal household and work activities. Relaxing muscles and relieving minor aches and pains. Emits energy at near infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Device Story

ElectroPulse-Pain Relief is a multi-modal device providing TENS, vibration, and near-infrared heat therapy. TENS component delivers electrical stimulation to muscles for pain relief; vibration component aids muscle relaxation; heat lamp component emits near-infrared energy for topical heating, increasing local blood circulation, and relieving minor muscle/joint pain, arthritis, and spasms. Device is intended for OTC use by patients for home-based pain management. Healthcare providers do not operate the device; patients self-administer therapy to address musculoskeletal discomfort. Output affects patient comfort by reducing pain and stiffness through physical stimulation and thermal energy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-modal device combining TENS (electrical stimulation), vibration, and near-infrared heat lamp. Operates as an OTC device. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching lower back muscles from exercise or daily activities; relaxing muscles; relieving minor aches/pains; providing topical heating for minor muscle/joint pain, arthritis, and muscle spasms; relieving stiffness; and increasing local blood circulation. Intended for OTC 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pain Relief Technologies % Mr. Kendall Gorham President 15048 SW Capstone Court Beaverton, Oregon 97007

9 2007 FEB

Re: K062532

Trade/Device Name: ElectroPulse - Pain Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH, ILY, IRO Dated: August 17, 2006 Received: August 18, 2006

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.

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. Kendall Gorham

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: k062532

Device Name: ElectroPulse-Pain Relief

Indications For Use:

Used for the temporary relief of pain associated with sore and TENS: aching muscles in the lower back due to strain from exercise, or normal household and work activities.

Relaxing muscles and relieving minor aches and pains. Vibration:

Emits energy at near infrared frequencies to provide topical Heat Lamp: heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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

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AND/OR

and Neurological Devices

**510(k) Number** L061376

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