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K Number
K040905
Device Name
WELLNESS/JOLIVETE
Manufacturer
TOHKAI PRECISION IND. LTD.
Date Cleared
2005-02-23

(322 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

By individuals or clinicians, to provide temporary relief from localized aches, pains and / or swelling caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a massaging device. This document does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, or any of the other specific details you requested regarding a device's performance study. It only states that the device is substantially equivalent to a legally marketed predicate device.

§ 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).