ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10

• K Number: K022925
• Device Name: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
• Manufacturer: BIOMEDICAL LIFE SYSTEMS, INC.
• Date Cleared: 2002-11-19 ( 76 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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-taumatic acute pain problems.

Device Description

Transcutaneous Electrical Nerve Stimulator (TENS) Model BMLS02-10

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (Electro-Nerve Stimulator TENS Model BMLS02-10). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to general regulatory requirements and contacts for further information.

Therefore, I cannot provide the requested information based on 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).