ELECTRO-NERVE STIMULATOR TENS, MODEL LX

• K Number: K990230
• Device Name: ELECTRO-NERVE STIMULATOR TENS, MODEL LX
• Manufacturer: BIOMEDICAL LIFE SYSTEMS, INC.
• Date Cleared: 1999-08-19 ( 206 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Abbreviated
• Panel: Neurology
• 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-traumatic acute pain problems.

Device Description

Electro-Nerve Stimulator, Tens, Model "LX"

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for an "Electro-Nerve Stimulator, Tens, Model 'LX'". It confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The letter only states the regulatory classification, indications for use, and confirms the device can be marketed.

Therefore, I cannot provide the requested table and information based on the input text. The 510(k) approval letter itself does not detail the technical study data.

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).