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Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and for the symptomatic relief of acute post traumatic pain problems.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "American Imex Premier Plus." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure (which is "symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems").

Since the document is a regulatory clearance letter and not a study report, it inherently cannot answer your specific questions related to acceptance criteria and study details.

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K Number

K982221

Device Name

PREMIER AP

Manufacturer

AMERICAN IMEX

Date Cleared

1998-09-22

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be 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

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Premier A-P," which is a Transcutaneous Electrical Nerve Stimulation (TENS) device. The letter states that the device is substantially equivalent to devices marketed before May 28, 1976.

Based on the provided document, the following questions cannot be answered as the document is an FDA clearance letter and does not contain detailed study information regarding acceptance criteria or device performance. This type of information is typically found in the 510(k) submission summary or a separate clinical study report, neither of which are provided here.

Therefore, for all the items requested (1 to 9), the answer is: The information is not available in the provided FDA 510(k) clearance letter.

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