ELECTROPULSE

K051128 · Pain Relief Technologies · GZJ · Mar 10, 2006 · Neurology

Device Facts

• Record ID: K051128
• Device Name: ELECTROPULSE
• Applicant: Pain Relief Technologies
• Product Code: GZJ · Neurology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain. Vibration Relaxing muscles and relieving minor aches and pains. Heat Lamp Emits energy at infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Device Story

ElectroPulse is a multi-modal therapeutic device combining TENS, vibration, and infrared heat lamp functions. TENS component provides electrical stimulation for chronic intractable pain and post-surgical/post-traumatic acute pain management. Vibration component facilitates muscle relaxation and minor ache relief. Infrared heat lamp emits energy to provide topical heating, relieve minor muscle/joint pain, reduce stiffness, and increase local blood circulation. Device is intended for prescription use. Healthcare providers utilize device to manage patient pain and musculoskeletal symptoms. Benefits include non-pharmacological pain relief and improved local circulation.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Multi-modal device integrating TENS (electrical stimulation), vibration (mechanical), and infrared heat lamp (thermal energy). Operates as a Class II device under 21 CFR 882.5890. No specific materials, software algorithms, or connectivity features described.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-surgical/post-traumatic acute pain, muscle relaxation, and relief of minor muscle/joint aches and stiffness via TENS, vibration, and infrared heat therapy.

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

MAR 1 0 2006

Mr. Kendall Gorham President Pain Relief Technologies 15440 N. 71 Street, #215 Scottsdale, Arizona 85254

Re: K051128

Trade Name: ElectroPulse Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ, ILY, IRO Dated: January 6, 2006 Received: January 11, 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

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## Page 2 - Mr. Kendall Gorham

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), 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.

Huber ne

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):_____K051128

Device Name:__ElectroPulse

Indications For Use:

TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.

Vibration Relaxing muscles and relieving minor aches and pains.

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

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Herluis Lemus G.

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

**510(k) Number** K051128