PREMIER PLUS

K032003 · American Imex · GZJ · Jan 7, 2004 · Neurology

Device Facts

• Record ID: K032003
• Device Name: PREMIER PLUS
• Applicant: American Imex
• Product Code: GZJ · Neurology
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transcutaneous Electrical Nerve Stimulation devices are used for the 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.

Device Story

The American Imex Premier Plus is a transcutaneous electrical nerve stimulator (TENS). It delivers electrical impulses to the skin to provide pain relief. The device is intended for use in the management of chronic intractable pain and acute post-surgical or post-traumatic pain. It is operated by a clinician or patient under prescription. The device functions by applying electrical stimulation to nerves to modulate pain signals.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Class II device. Regulation 21 CFR 882.5890. Product code GZJ.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain and as adjunctive treatment for post-surgical and post-traumatic acute pain.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Mr. Alex Fong Regulatory Affairs Manager American Imex 16520 Aston Street Irvine, California 92606

Re: K032003

Trade/Device Name: American Imex Premier Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: December 5, 2003 Received: December 5, 2003

Dear Mr Fong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your so determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosale) to regions and ment date of the Medical Device Amendments. or to conniner of the ridge 2011-03-2018 accordance with the provisions of the Federal Food. Drug. ue vices that have neen require approval of a premarket approval application (PMA). and cosmede ror (free) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is oldssined (600 a007 of ols. Existing major regulations all'ecting your device can may be subject to satifical Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devined a determination that your device complies with other requirements of the Act than + Federal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N Fart 6075; accession (21 CFR Part 820); and if applicable, the electronic form in the quarty bysions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Alex Fong

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your dovice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

2-Madi-N-Mullins

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) number (if known):

Premier Plus Device name:

American Imex Sponsor name:

Indications for use: Transcutaneous Electrical Nerve Stimulation devices are
s and a Indications for use: Transculations brochronic intractable pain and used for the symptomatic refrer and management of early of and post traumatic acute pain problems.

Do not write below this line - continue on another page if necessary

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wi

Prescription Use

Over-The-Counter Use [ ]

C. Mark McMillan

(Division sign-off) Division of General, Restorative and Neurological Devices

510(k) Number K032003