(46 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is limited to a basic traction unit.
Yes
The "Intended Use / Indications for Use" explicitly states that the device is for "MEDICAL PURPOSES" and is used to "EXERT THERADITIC RULLIN ON THE PATIENTYS, BOD FORES," clearly indicating a therapeutic intent.
No
The intended use statement describes a therapeutic function ("EXERT THERADITIC RULLIN ON THE PATIENTYS BOD FORES 890,5900 PIMARIC FOR THE LERVICAL - LUMBAR") for patient bodies, not a diagnostic one.
No
The device description explicitly states "Dynatron 900 Traction Unit," which is a hardware device used for traction therapy. The intended use also mentions "TRACTION ACCESSORIES" and "HARNESSES," further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "FOR MEDICAL PURPOSES 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". This describes a physical therapy or rehabilitation device that applies force to the body.
- Device Description: "Dynatron 900 Traction Unit" further supports the idea of a physical therapy device.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or any other activities typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply physical force for therapeutic purposes, which falls outside the scope of IVD.
N/A
Intended 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
Product codes
ITH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5900 Power traction equipment.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines above a wavy line.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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