ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3

• K Number: K021271
• Device Name: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
• Manufacturer: BIOMEDICAL LIFE SYSTEMS
• Date Cleared: 2003-02-06 ( 290 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• 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

(TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS02-3

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Electro-Nerve Stimulator TENS Model BMLS02-3." This type of document determines substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, or details like sample size, expert qualifications, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The document is strictly a regulatory approval letter based on substantial equivalence.

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).