P-STIM SYSTEM

K050123 · Neuroscience Therapy Corp. · BWK · Mar 30, 2006 · NE

Device Facts

• Record ID: K050123
• Device Name: P-STIM SYSTEM
• Applicant: Neuroscience Therapy Corp.
• Product Code: BWK · NE
• Decision Date: Mar 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The P-Stim is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points.

Device Story

P-Stim is a miniaturized, battery-powered, transcutaneous electrical nerve stimulator (TENS) for auricular acupuncture. Device connects via three stainless steel wires to acupuncture needles inserted into auricular points. Operates on a pre-programmed cycle: 180 minutes on, 180 minutes off, for up to 96 hours. Powered by three 1.4V zinc air batteries. Used by qualified acupuncture practitioners to provide electrical stimulation to acupuncture points. Output parameters (frequency, pulse, duration) are pre-programmed. Intended to assist in acupuncture therapy.

Clinical Evidence

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

Technological Characteristics

Miniaturized, battery-powered TENS device. Power source: three 1.4V zinc air batteries. Output: single channel, pre-programmed frequency, pulse, and duration. Interface: three stainless steel wires connecting to acupuncture needles. Conductive gel used at electrode-skin interface. Non-sterile components (needles applied by practitioner).

Indications for Use

Indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Predicate Devices

• Acu-Stim (K014273)

Submission Summary (Full Text)

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MAR 3 0 2006

## P-STIM 510(k) SUMMARY

### (As required by 21 C.F.R. § § 807.87(h), 807.92)

#### Date of Submission

January 17, 2005

#### Identification of Applicant

Applicant

NeuroScience Therapy Corp. 135 Lake St. So., #100 Kirkland, WA 98033

Contact Person

Richard J. Forsell Corporate Secretary 425-889-4659 [e-mail]

| Trade or Proprietary Name |
|---------------------------|
| Common Name |
| Classification Name |
| Classification |

P-Stim Electro-acupuncture device Electro-acupuncture stimulator Unclassified

#### Predicate Device

The legally marketed predicate device to which the P-Stim is substantially equivalent is the Acu-Stim (K014273).

#### Intended Use

The P-Stim is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points.

#### Device Description

The P-Stim is a miniaturized, battery-powered, transcutaneous electrical nerve stimulator that has a pre-programmed frequency, pulse, and duration for the stimulation of auricular acupuncture points. The device connects via three stainless steel wires to acupuncture needles that have been applied to the appropriate auricular acupuncture points. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours.

NeuroScience Therapy Corp. CONFIDENTIAL

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# Summary of Technological Characteristics

Substantial equivalence is claimed because the P-Stim has the same intended use and similar operating principles to the Acu-Stim. Both devices are transcutaneous electrical nerve stimulators with a single output channel and mode and similar pulse widths and frequencies. Both use a conductive gel between the electrode and the patient's skin. Technical differences do not affect the safety or efficacy of the product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and head. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2006

Neuroscience Therapy Corp. c/o Jan McComb, Ph. D. ICRC, Inc. 22691 Lambert Street Suite 517 Lake Forest, California 92630

Rc: K050123

Trade/Device Name: P-Stim System Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: January 20, 2006 Received: January 23, 2006

Dear Dr. McComb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2- Dr. Jan McComb

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 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), 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/industry/support/index.html.

Sincerely yours,

Hulbert Ziemer as

Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

K050123

Device Name:

P-Stim System

Indications For Use:

P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Semer
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K050123