PREMIER AP

K982221 · American Imex · GZJ · Sep 22, 1998 · Neurology

Device Facts

• Record ID: K982221
• Device Name: PREMIER AP
• Applicant: American Imex
• Product Code: GZJ · Neurology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Premier A-P is a Transcutaneous Electrical Nerve Stimulation (TENS) device. It delivers electrical impulses to nerves via skin electrodes to manage pain. Used for chronic intractable pain and post-surgical/post-traumatic acute pain. Operated by patients or clinicians in clinical or home settings. Provides symptomatic relief by modulating pain signals.

Clinical Evidence

No clinical data provided; substantial equivalence is based on established TENS technology.

Technological Characteristics

TENS device; electrical stimulation via skin electrodes; portable form factor; prescription use.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Mr. Joe Fong American Imex 16520 Aston Street Irvine, California 92606

Re: K982221 Premier A-P Regulatory Class: II Product Code: GZJ Dated: June 4, 1998 Received: June 24, 1998

Dear Mr. Fonq:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic ... . . . . . . . . Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Mr. Joe Fong

This letter will allow you to begin marketing your device as described in your 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 device 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ___ K 9 8 2 2 2 |

PREMIER - A - P Device Name:

Indications For 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982221

Prescription Use ... . . . . . . . . . . . . OR (Per 21 CFR 801-109) ---------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use ‫(1980-11-2012) Over-The

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