SMART TENS, MODEL: D-BC05T

• K Number: K091045
• Device Name: SMART TENS, MODEL: D-BC05T
• Manufacturer: BODY CLOCK HEALTH CARE LTD
• Date Cleared: 2009-12-18 ( 249 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "Smart TENS, Model: D-BC05T." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt. This document is solely a regulatory clearance letter and does not include the technical study report.

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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).