K Number
K001361Device Name
JILCO TRACTION-FLEXION CHAIRManufacturer
Date Cleared
2000-07-19
(82 days)
Product Code
Regulation Number
890.5900Type
TraditionalPanel
PMReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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).