SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR

K973914 · Sense Technology, Inc. · LXM · Jun 30, 1998 · PM

Device Facts

• Record ID: K973914
• Device Name: SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
• Applicant: Sense Technology, Inc.
• Product Code: LXM · PM
• Decision Date: Jun 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

Device Story

PulStarFRAS is a device used for the treatment of musculoskeletal conditions. It targets pain related to joint subluxation, restricted mobility, myofacial spasm, and ligamentous strain. The device is intended for prescription use by healthcare professionals in a clinical setting to assist in managing patient musculoskeletal health.

Clinical Evidence

No clinical data provided in the document.

Indications for Use

Indicated for patients experiencing musculoskeletal pain associated with joint subluxation, restricted joint mobility, myofacial spasm, or ligamentous strain.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Joseph M. Evans, Ph.D. · President Sense Technology Inc. 3251 Old Frankstown Road Pittsburgh, Pennsylvania 15239

Re: K973914 Trade Name: PulStarFRAS Regulatory Class: Unclassified Product Code: LXM Dated: May 15, 1998 Received: May 26, 1998

Dear Dr. Evans:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulations.

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.

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Page 2 - Joseph M. Evans, Ph.D

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). 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 at [phone], or at its Internet address "http://www.fda.gov/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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Image /page/2/Picture/0 description: The image shows the logo for Sense Technology Inc. The logo features a stylized "STI" in bold, black font, with the words "SENSE TECHNOLOGY INC." in a smaller, serif font to the right of the letters. The letters "STI" are stacked vertically, with each letter having a series of horizontal lines running through it.

Image /page/2/Picture/1 description: The image shows a bar graph with 10 bars. The bars are all vertical and have the same width. The height of the bars varies, with the tallest bar being the third from the left. The bars are all filled with a dark gray color. The bars appear to be increasing in height from left to right, then decreasing, and then increasing again.

K973914

Indications for Use

Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

Prescription Use
(Per 21 CFR 801.109)

Piccolo

Divisio Sian-Off Division of General Restorative Devices 510(k) Num

6/29/98