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K Number
K150269
Device Name
Ballancer 505 System, Model 1201-AC
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2015-05-26

(111 days)

Product Code
IRP
Regulation Number
890.5650
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.

The Ballancer 505 System is indicated for:

  • Simulating kneading and stroking of the tissues by use of an inflatable garment

  • Temporary increase circulation in areas which the garment is applied

  • Temporary relief of minor muscle aches and pains

Device Description

Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The text is a letter from the FDA regarding a 510(k) premarket notification for the Ballancer 505 System, Model 1201-AC, and includes its indications for use. It does not include a detailed study report or acceptance criteria for device performance.

§ 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).