(311 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the ElectroPulse device. It states that the device is substantially equivalent to legally marketed predicate devices. This type of letter does not typically contain information about comprehensive clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are usually part of a full clinical trial report or a more detailed submission.
Based on the provided text, the specific information requested cannot be extracted. The document confirms the FDA's clearance of the device based on substantial equivalence, implying that the performance of the ElectroPulse is considered comparable to similar devices already on the market, but it does not detail a study conducted by the applicant to prove specific acceptance criteria for the device itself.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details as this document is not a clinical study report.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 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.
Page 1 of _1 _________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051128
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).