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K Number
K993919
Device Name
DYNATRON 900
Manufacturer
DYNATRONICS CORP.
Date Cleared
2000-01-03

(46 days)

Product Code
ITH
Regulation Number
890.5900
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 Description

Dynatron 900 Traction Unit

AI/ML Overview

This document is a 510(k) clearance letter for the Dynatron 900 Traction Unit. It does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, ground truth establishment, or study designs (MRMC, standalone).

Therefore, I cannot provide answers to your specific questions based on the provided text. The letter only confirms that the FDA has found the Dynatron 900 Traction Unit to be substantially equivalent to a legally marketed predicate device for its indicated uses.

§ 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).