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K Number
K040824
Device Name
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
Manufacturer
BIOMEDICAL LIFE SYSTEMS, INC.
Date Cleared
2004-04-29

(30 days)

Product Code
LIH
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.

Device Description

Interferential Stimulator Model BMLS03-6

AI/ML Overview

The provided text is a 510(k) clearance letter for an Interferential Stimulator, Model BMLS03-6. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table and study description based on the provided text. The document is solely a regulatory clearance letter, not a technical report or study summary.

§ 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).