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K Number
K010292
Device Name
DRX 2000
Manufacturer
AXIOM WORLDWIDE, INC.
Date Cleared
2001-05-01

(90 days)

Product Code
ITH
Regulation Number
890.5900
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
K022602
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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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).