ULTRASTIM KIT

K013532 · Axelgaard Mfg. Co., Ltd. · GZJ · Aug 22, 2002 · Neurology

Device Facts

• Record ID: K013532
• Device Name: ULTRASTIM KIT
• Applicant: Axelgaard Mfg. Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Device Story

UltraStim Kit comprises transcutaneous electrical nerve stimulation (TENS) components, including cutaneous electrodes and a truncal orthosis; designed for over-the-counter (OTC) use. Device delivers electrical stimulation to muscles to provide temporary pain relief. Intended for patient self-application in home settings to manage muscle soreness from strain. Healthcare providers do not operate the device; patients use it independently to alleviate discomfort and improve quality of life during recovery from minor physical exertion.

Clinical Evidence

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

Technological Characteristics

System includes cutaneous electrodes and truncal orthosis for TENS application. Operates via electrical stimulation. Class II device under 21 CFR 882.5890, 882.1320, and 890.3490. Product codes GZJ, GXY, IQE.

Indications for Use

Indicated for temporary relief of lower back pain caused by muscle strain from exercise or daily activities in adults.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 28 2003

Dan Jeffery Axelgaard Mfg. Co., Ltd. 1667 S. Mission Road Fallbrook, California 92028-4115

Re: K013532

Trade/Device Name: UltraStim Kit Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320 and 21 CFR 890.3490 Regulation Name: Transcutaneous Electrical Nerve Stimulator, Cutaneous Electrode and Truncal Orthosis

Regulatory Class: Class II Product Code: GZJ, GXY and IQE Dated: May 28, 2002 Received: June 6, 2002

Dear Mr. Jeffery:

This letter corrects our substantially equivalent letter of August 22, 2002 to clarify the over-the-counter (OTC) status of your device.

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 (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 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.

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## Page 2 - Mr. Dan Jeffery

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.

This letter will allow you to continue 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H. Mulkusa

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

510(k) Number (if known): K013532

Device Name: UltraStim Kit

Indications for Use:

The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter (OTC) Use

l. Mark N. Millman

al, Restorative

510(k) N