DYNATRON 900

K993919 · Dynatronics Corp. · ITH · Jan 3, 2000 · Physical Medicine

Device Facts

• Record ID: K993919
• Device Name: DYNATRON 900
• Applicant: Dynatronics Corp.
• Product Code: ITH · Physical Medicine
• Decision Date: Jan 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR MEDICAL PURFOSES USE FOIZ ILLATENDED with TRATION ACCESSORIES, such AS IN CONSUNCTION RECTS HAWESSES TO EXERT THERADITIC RULLIN ON THE PATIENTYS, BOD FORES 890,5900 PIMARIC FOR THE LERVICAL - LUMBAR

Device Story

Dynatron 900 is a traction unit designed to exert therapeutic pulling forces on a patient's body. Used in clinical settings by healthcare professionals, the device operates in conjunction with traction accessories and harnesses to provide cervical or lumbar traction. It functions as a mechanical system to deliver controlled force to the patient, aiding in therapeutic treatment. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical traction unit; intended for cervical and lumbar application; operates with external harnesses and accessories; classified under 21 CFR 890.5900.

Indications for Use

Indicated for patients requiring therapeutic traction to the cervical or lumbar spine, applied via traction accessories and harnesses.

Regulatory Classification

Identification

Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2000

Mr. John S. Ramey Vice President of Operations and Regulatory Affairs Dynatronics Corporation 7030 Park Centre Drive Salt Lake City. Utah 84121

K993919 Re: Trade Name: Dynatron 900 Traction Unit Regulatory Class: II Product Code: ITH Dated: November 16, 1999 Received: November 18, 1999

Dear Mr. Ramey:

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.

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Page 2 - Mr. John S. Ramey

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 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Jessa C. Key

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) NUMBER (IF KNOWN): L993919

DEVICE NAME: DYNATRON 900

INDICATIONS FOR USE:

INDICATIONS FOR USE:

FOR MEDICAL PURFOSES USE FOIZ ILLATENDED with TRATION ACCESSORIES, such AS IN CONSUNCTION RECTS HAWESSES TO EXERT THERADITIC RULLIN ON THE PATIENTYS, BOD FORES 890,5900 PIMARIC FOR THE LERVICAL - LUMBAR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over - The - Counter - Use (Optional Format 1-2-5

Kimil Layan in Jyp

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