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K Number
K033455
Device Name
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
Manufacturer
BIOMEDICAL LIFE SYSTEMS, INC.
Date Cleared
2004-01-15

(77 days)

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

Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Device Description

(TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS03-5

AI/ML Overview

I'm sorry, but this document is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.

This document does not contain information about:

  • Acceptance criteria or reported device performance.
  • Any specific study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

§ 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).