TENS PRO 900

• K Number: K023726
• Device Name: TENS PRO 900
• Manufacturer: ACUMED MEDICAL SUPPLIES, LTD.
• Date Cleared: 2003-06-17 ( 223 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

for use as an adjunct device for the symptomatic relief and management of chronic intractable d. pain

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a regulatory clearance letter and does not contain the information requested about acceptance criteria or a study proving device performance. The letter confirms that the TENS Pro 900 device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. It does not include details on specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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).