BODIHEALTH SYSTEM

• K Number: K052836
• Device Name: BODIHEALTH SYSTEM
• Manufacturer: USA LASER THERAPEUTICS, INC.
• Date Cleared: 2007-02-13 ( 495 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K121578 , K131675

Intended 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.

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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).