(495 days)
The BodiHealth System is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Not Found
The provided text is a 510(k) premarket notification summary for the BodiHealth System, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.
Unfortunately, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance.
Here's why and what information is missing:
- No Acceptance Criteria or Performance Data: The document is a regulatory approval letter based on "substantial equivalence" to a predicate device. It explicitly states, "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." This means the FDA did not independently verify performance metrics, but rather determined it was similar enough to an already approved device.
- No Study Details: There is no mention of any specific study (clinical trial, performance study, etc.) that would include details like sample size, data provenance, expert qualifications, ground truth methods, or effect sizes for AI assistance. The approval is based on "substantial equivalence" to a predicate device, not on a new performance study demonstrating specific criteria were met.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study's methodology, as this information is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three bars extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
USA Laser Therapeutics, Inc. c/o M. Joyce Heinrich Texas Applied Biomedical Services 12101 Cullen Boulevard, #A Houston, Texas 77047
FEB 1 3 2007
Re: K052836
Trade/Device Name: BodiHealth System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: November 14, 2006 Received: November 16, 2006
Dear Ms Heinrich:
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 - M. Joyce Heinrich
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BodiHealth System 510(k) Notification October 7, 2005
APPENDIX A
Indications for Use
510(k) Number (if known):
Pending
Device Name:
ר
BodiHealth System
Indications for Use:
The BodiHealth System is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODpE)
Division 1-6 11 Division of General, Restorative, Neurological Devices
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§ 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).