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K Number
K222206
Device Name
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
Manufacturer
Shenzhen Dongjilian Medical Tech Co., Ltd.
Date Cleared
2022-09-30

(67 days)

Product Code
IRP
Regulation Number
890.5650
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).